PH - Prisma Health

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (C-Guardians)

Contact(s):

Diane Blain - diane.blain@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 19 years to 80 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04900844

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Inclusion Criteria:

• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
• Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
• Life expectancy ≥ 24 months from the date of the index procedure.
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
• Subject has a modified Rankin Score of ≤ 2at the time of informed consent.
• Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:
• Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis. Or
• Asymptomatic carotid stenosis ≥ 80%
• Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the following criteria:
• Age ≥ 70 (maximum 80 years)
• CCS angina class 3-4 or unstable angina
• Congestive Heart Failure (CHF) NYHA class III-IV
• Left ventricular ejection fraction (LVEF) ≤ 35%
• MI ≥ 72 hours and \< 6 weeks pre-procedure
• Multi-vessel CAD (≥ 2 vessels \>70% stenosis) and history of angina
• Chronic Obstructive Pulmonary Disease (COPD) with FEV1\<50
• Permanent contralateral cranial nerve injury/paralysis
• Restenosis from previous carotid endarterectomy (CEA)
• Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31-60 days after CAS
• Abdominal aortic aneurysm repair or peripheral vascular surgery is planned between 31 to 60 days after CAS. OR
• High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:
• Occlusion of the contralateral CCA or ICA.
• Prior radiation treatment to the neck or a radical neck dissection.
• Severe bilateral ICA stenosis requiring treatment.
• Target lesion at or above the level of the jaw (C2) or below the clavicle.
• Severe tandem lesions
• Inability to extend the hear due to cervical disorders.
• Laryngeal palsy or laryngectomy.
• Prior head and neck surgery in the region of the carotid artery.
• Tracheostomy or tracheostoma.
• Spinal immobility of the neck.
• Hostile neck or surgically inaccessible lesion.
• Angiographic General Inclusion Criteria, i.e., meets all the following criteria:
• Target lesion location at the carotid bifurcation and/or proximal internal carotid artery (ICA)
• Vessel distal to target lesion can accommodate a distal embolic protection device (EPD), and EPD is compatible with CGuard™ device (refer to CGuard™ System IFU for specific EPDs).
• Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.
• Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.

Exclusion Criteria:

• Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
• Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
• Type III or bovine aortic arch.
• Total occlusion of the target vessel.
• Presence of "String sign" of the target lesion.
• In-tandem lesions with \>= 50% or \>= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
• History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
• Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.
• Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).
• Known reason for potential stroke other than carotid artery stenosis, including history of atrial fibrillation or other sources of thromboemboli within the past 12 months.
• History of thrombophilia.
• Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or other anticoagulant/ antiplatelet therapies.
• Contrast media sensitivity or allergy that cannot be pre-treated.
• Previous stent placement in the target vessel.
• Evolving stroke or intracranial hemorrhage, or history of previous intracranial hemorrhage or brain surgery within the past 12 months.
• Major neurologic deficit with NIHSS of ≥ 15.
• Dementia or other neurologic condition confounding the neurologic assessment.
• Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
• Subject previously enrolled in this clinical trial.
• Possible / probable non-compliance of subject with protocol required follow up or medication.
• Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this C-GUARDIANS Pivotal IDE Clinical Study.
• SARS-CoV2 (COVID-19) active infection.

Interventions: DEVICE: CGuard Carotid Stent implantation

Conditions: Carotid Artery Stenosis

Keywords: Carotid Stenosis, Stenting, Prospective study, Embolic Protection Device (EPD), Carotid Artery Diseases, Cerebrovascular Disorders, Constriction, Pathologic

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Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05554367

Show full eligibility criteria

Inclusion Criteria:

* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-A3 based on the presence of an actionable mutation as defined in EAY191. * GENERAL ComboMATCH EAY191 REGISTRATION INCLUSION CRITERIA: * Patients must be enrolled on the EAY191 registration study and be assigned to this protocol by EAY191 * Patients must have KRAS/NRAS/HRAS or RAF mutations or rare RAF fusions as determined by the ComboMATCH screening assessment * Patients with low grade serous ovarian cancer who have progressed on a prior MEK inhibitor are not required to have a KRAS/NRAS/HRAS or BRAF alteration * Patients must not have a BRAF V600E alteration as determined by the ComboMATCH screening assessment * Patients with a tumor harboring KRAS G12C mutation will be eligible either after they have received a G12C inhibitor or can be enrolled if they do not meet eligibility for a G12C inhibitor. However, patients with tumors harboring KRAS G12C mutation will be prioritized for a G12C inhibitor-based substudy if eligible * Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration * Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website * EAY191-A3 IELIGIBILITY CRITERIA: * Histologically confirmed cancer for each cohort for which curable treatment modalities are not an option. Rare BRAF fusions and non-BRAF V600E aMOIs are acceptable. RB1 mutations or two copy RB1 deletions are excluded * Tumor tissue must be available: * Adequate archival tumor specimen (obtained within 12 months of EAY191 registration which has not had a Response Evaluation Criteria in Solid Tumors (RECIST) response, complete response (CR) or partial response (PR), to any intervening therapy after collection of the tissue) must be available with formalin-fixed paraffin-embedded tumor tissue (blocks or slides) OR * Consent to a new tumor tissue biopsy which is not a representative target lesion. This lesion must be amenable to a minimal risk image-guided or direct vision biopsy A new biopsy is preferred but is not required for enrollment in EAY191-A3 if sufficient archival tissue is available as described above * Measurable disease per RECIST 1.1. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to registration * COHORT 1: Low grade serous ovarian cancer with KRAS, NRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable * COHORT 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy * COHORT 1: Any number of prior therapies permitted * COHORT 1: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks prior to registration * COHORT 1: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to registration * COHORT 2: Low grade serous ovarian cancer * COHORT 2: Prior progression of disease on a MEK inhibitor (prior binimetinib permitted) * COHORT 2: If patient has previously received binimetinib, they cannot have required dose reduction or discontinuation of binimetinib due to adverse events * COHORT 2: No prior receipt of a CDK4/6 inhibitor * COHORT 2: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks prior to registration * COHORT 2: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to registration * COHORT 3: Pancreatic cancer with KRAS/NRAS/HRAS, non-BRAF V600E aMOIs or rare RAF fusions are acceptable * COHORT 3: No prior MEK inhibitor (MEKi) and CDK4/6i therapy * COHORT 3: Progression after at least one line of prior therapy as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit * COHORT 3: Any number of prior therapies are permitted * COHORT 3: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks prior to registration * COHORT 3: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to registration * COHORT 4: KRAS/NRAS/HRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable * COHORT 4: No prior MEKi and CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit * COHORT 4: Any number of prior therapies are permitted * COHORT 4: No more than 6 patients with a given tumor type allowed in this cohort * COHORT 4: Any tumor type, except: LGSOC/NSCLC/CRC/pancreatic/melanoma * COHORT 4: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks prior to registration * COHORT 4: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to registration * Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \>= 30 mL/min as calculated by the Cockcroft-Gault formula * Total bilirubin =\< 1.5 x upper limit of normal (ULN). Patients with Gilbert syndrome may enroll if total bilirubin (bili) \< 3 mg/dL (51 micromole/L) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Creatine phosphokinase (CPK) =\< 2.5 x ULN * Patients must be able to swallow oral formulations of the agents * No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months * No patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease * No active skin disorder that has required systemic therapy within the past 1 year * No history of rhabdomyolysis * No concurrent ocular disorders including: * Subjects with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes * Subject with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO * Subjects with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions * No patients with a history of hypersensitivity to any of the study drug(s) * No prior allogeneic stem cell or solid organ transplantation * Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) and patient off of systemic steroids, and brain metastases stable for at least 1 month * No residual Common Terminology Criteria for Adverse Events (CTCAE) \>= grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients whose left ventricular ejection fraction (LVEF) has been evaluated by echocardiography (ECHO)/multigated acquisition scan (MUGA) are excluded if the most recent exam shows an LVEF \< 50% * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment * No exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of therapy * Patients treated with Cohort 1 control treatment binimetinib who experience disease progression may elect to migrate to cohort 2 and receive combination treatment with palbociclib and binimetinib. Patients who choose to do so must meet laboratory values and performance status requirements as above and must be begin treatment within 21 days. For patients who migrate from cohort 1 to cohort 2, the 28-day window restricting prior anti-cancer directed therapies does not apply to prior binimetinib. A new biopsy will not be required for migration, but the optional biopsy at disease progression should be encouraged

Interventions: DRUG: Binimetinib, PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Palbociclib

Conditions: Exocrine Pancreas Carcinoma, Malignant Solid Neoplasm, Ovarian Low Grade Serous Adenocarcinoma, Stage IV Ovarian Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

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Project: Every Child for Younger Patients With Cancer

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: Up to 25 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT02402244

Show full eligibility criteria

Inclusion Criteria:

* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem * Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority * Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows: * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant) * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant * The following other benign/borderline conditions: * Mesoblastic nephroma * Teratomas (mature and immature types) * Myeloproliferative diseases including transient myeloproliferative disease * Langerhans cell histiocytosis * Lymphoproliferative diseases * Desmoid tumors * Gonadal stromal cell tumors * Neuroendocrine tumors including pheochromocytoma * Melanocytic tumors, except clearly benign nevi * Ganglioneuromas * Subjects must be =\< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \[NCTN\]) therapeutic study, for which there is a higher upper age limit * All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1

Interventions: OTHER: Cytology Specimen Collection Procedure, OTHER: Medical Chart Review

Conditions: Malignant Solid Neoplasm, Congenital Mesoblastic Nephroma, Neoplasm of Uncertain Malignant Potential, Adrenal Gland Pheochromocytoma, Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Stromal Neoplasm, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neuroendocrine Neoplasm

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Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application (SYN 20-01)

Contact(s):

Abby Birrell - Abby.Birrell@PrismaHealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years to 80 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05094089

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Interventions: DEVICE: Hernia repair with mesh

Conditions: Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral

Keywords: Hernia Repair, Hernia Mesh Treatment, Ventral Hernia, Incisional Hernia, Intraperitoneal, Preperitoneal

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REal-World Analyses of Stroke - Thrombus Occlusion REtrieval ("RESTORE")

Contact(s):

Michelle Wetherby - michelle.wetherby@microvention.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age:

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04451525

Show full eligibility criteria

Cohort I:

Inclusion Criteria:

• Patient is ≥ 21 and ≤ 85 years of age.
• Patient has a pre-morbid mRS ≤ 1.
• Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
• Patient has an NIHSS score ≥ 5 at time of intervention.
• Symptom onset is within 8 hours of when groin puncture can be achieved.
• Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient will be treated using the direct aspiration as first line treatment technique and the decision to use this technique and the study device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent.
• Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.

Exclusion Criteria:

• Inability to obtain written informed consent.
• Patient is \< 21 or \> 85 years of age.
• Patient has a pre-morbid mRS ≥ 2.
• More than 8 hours have passed since symptom onset.
• Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
• Presence of a pre-existing large territory infarction.
• Absent femoral pulses or other condition preventing femoral access.
• Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
• Patient is pregnant.
• Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
• Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
• The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
• Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
• Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
• Patient is enrolled in another device or drug study in which participation could confound study results.
• Imaging (CT or MR) exclusion criteria: * Presence of intracerebral hemorrhage as evidenced on initial imaging * Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries) * Significant mass effect with midline shift * Evidence of intracranial tumor * Baseline ischemic core lesion \>50 cc * Involvement of \> 1/3 of the middle cerebral artery territory * ASPECTS \<6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment) Cohort II:

Inclusion Criteria:

• Neuroimaging (CT/CTA and/or MR/MRA) demonstrates intracranial vessel occlusion.
• Symptom onset is within 24 hours of when arterial access puncture can be achieved.
• Patient will be treated using an FDA-cleared/approved and market-released MicroVention mechanical thrombectomy device as the initial, primary treatment device and the decision to use this device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment. Note: For the purposes of this protocol, ancillary/accessory devices such as balloon guide catheters and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent within 48 hours of procedure.

Exclusion Criteria:

• Inability to obtain written informed consent within 48 hours of procedure.
• Patient is enrolled in another device or drug study in which participation could confound study results.

Interventions: DEVICE: MicroVention Mechanical Thrombectomy Devices as first-line treatment

Conditions: Acute Ischemic Stroke, Vessel Occlusion, Stroke, Ischemic

Keywords: Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®

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Intravesical BCG vs GEMDOCE in NMIBC (BRIDGE)

Contact(s):

Max Kates, MD - mkates@jhmi.edu

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05538663

Show full eligibility criteria

Inclusion Criteria:

* Patient must be \> 18 years of age. * Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization. * Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease. * Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT. * Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization. NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible. * Patient must not have pure squamous cell carcinoma or adenocarcinoma. * Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell). * Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patient must have ECOG Performance Status 0-2. * Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy. * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization): Leukocytes ≥ 3,000/mcL Leukocytes:__________ Date of Test:__________ Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC:__________ Date of Test:__________ Platelets ≥ 70,000/mcL Platelets:__________ Date of Test:__________ Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin:__________ Institutional ULN:_________ Date of Test:__________ AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST:_______ Institutional ULN:_________ Date of Test:_______ ALT: _______Institutional ULN:_________ * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Exclusion Criteria:

* Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast. NOTE: If a patient's renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable. NOTE: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.
• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Patient of child bearing potential? ______ (Yes or No) Date of blood test or urine study: ___________ * Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition,patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment. * Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.

Interventions: DRUG: Gemcitabine, DRUG: Docetaxel, DRUG: Bacillus Calmette Guerin

Conditions: Non-muscle-invasive Bladder Cancer

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Glycemic Control After Antenatal Corticosteroids in Women with Pregestational and Gestational Diabetes

Contact(s):

Daniel Pasko, MD - daniel.pasko@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: Up to 50 years old

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04542148

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Interventions: DRUG: Sliding Scale Insulin, DRUG: Up-Titration of Home Insulin, DRUG: Continuous Insulin Infusion, DEVICE: Dexcom G6 Professional Continuous Glucose Monitor

Conditions: Diabetes Mellitus, Type 2, Preterm Birth, Pregnancy, High Risk, Diabetes, Gestational

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Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Contact(s):

Gwen Nichols, MD - gwen.nichols@lls.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 29 days to 21 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05183035

Show full eligibility criteria

Inclusion Criteria * Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/LLS territory). * Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment. * Participants must have one of the following: * Children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation in:
• Second relapse, who are sufficiently fit to undergo another round of intensive chemotherapy
• First relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy. * Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score) * Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:
• Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.
• Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and/or hydrocortisone.
• Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.
• Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.
• Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.
• Radiation therapy (RT) (before start of protocol treatment): * ≥ 14 days have elapsed for local palliative RT (small port); * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis; * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.
• Stem Cell Infusions (before start of protocol treatment): * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \[TBI\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \[DLI\]) * No evidence of active graft versus host disease (GVHD).
• Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.
• Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \[NK\] cells, dendritic cells, etc.) before start of protocol treatment.
• Participants with prior exposure to venetoclax are eligible in this trial * Adequate organ function:
• Adequate Renal Function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml/min/1.73 m\^2, or * Normal serum creatinine based on age/sex
• Adequate Liver Function defined as: * Direct bilirubin \< 1.5 x upper limit of normal (ULN), and * Alkaline phosphatase ≤ 2.5 x ULN, and * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If liver abnormality is due to radiographically identifiable leukemia infiltrate, the participant will remain eligible.
• Cardiac performance: Minimum cardiac function defined as: * No history of congestive heart failure in need of medical treatment * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \[SF\] \< 25% or ejection fraction \[EF\] \< 40%) * No signs of congestive heart failure at presentation of relapse. * Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation. Exclusion Criteria * Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible. * Participants with Down syndrome. * Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML). * Participants with isolated CNS3 disease or symptomatic CNS3 disease. * Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax. * Participants who are currently receiving another investigational drug (GO is not considered investigational in this study). * Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome. * Participants with known prior allergy to any of the medications used in protocol therapy. * Participants with documented active, uncontrolled infection at the time of study entry. * No known human immunodeficiency virus (HIV) infection. * Post menarchal female participants with positive pregnancy test. * Concomitant Medications * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment. * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment. * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC). * Pregnancy or Breast-Feeding: * Participants who are pregnant or breast-feeding. * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per clinical trials facilitation group (CTFG) guidelines for the duration of study therapy and for 6 months after the completion of all study therapy. * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and for 4 months after the completion of all study therapy. Additional criteria to receive a gemtuzumab ozogamicin infusion: Gemtuzumab ozogamicin should not be given: * to participants with history of veno-occlusive disease (VOD)/Sinusoidal obstruction syndrome (SOS) grade 4 * to participants with history of VOD/SOS grade 3 * to participants with CD33 negative leukemic blasts (determined at local lab) Note that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.

Interventions: DRUG: Fludarabine, DRUG: Cytarabine, DRUG: Gemtuzumab Ozogamicin, DRUG: Azacitidine, DRUG: Venetoclax

Conditions: Acute Myeloid Leukemia

Keywords: Venetoclax, Gemtuzumab Ozogamicin, Fludarabine, Cytarabine, Relapsed refractory, Azacitidine

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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Contact(s):

BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 12 years to 75 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04991935

Show full eligibility criteria

Inclusion Criteria:

* Previously participated in prior clinical study CC-93538-EE-001 and either:
• Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
• Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
• Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
• Subject completed Week 48 of the Maintenance Phase * OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit * Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies. * Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator. * Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.

Exclusion Criteria:

* Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study. * Active Helicobacter pylori infection or esophageal varices. * Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study. * Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study. * Received an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during the CC-93538-EE-001 or CC-93538-DDI-001 studies are not eligible to participate, unless allowed following a discussion with the Clinical Trial Physician. * Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study. * Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality). * Active parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (viral hepatitis, tuberculosis, or HIV) * Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538. * Females who are pregnant or lactating.

Interventions: DRUG: CC-93538

Conditions: Eosinophilic Esophagitis

Keywords: Eosinophilic Esophagitis, CC-93538, RPC4046, Adult, Adolescent, Gastrointestinal Diseases, Esophagitis, Gastroenteritis, Eosinophils, Eosinophilia, Esophageal Diseases, Allergic Diseases, Antibody, Monoclonal, Hypersensitivity, Immunologic factors, Physiological Effects of Drugs, Cendakimab

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Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial (COPE)

Contact(s):

Stephanie Tanner - stephanie.tanner@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04274530

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Interventions: BEHAVIORAL: Cognitive Behavioural Therapy

Conditions: Pain, Postoperative, Pain, Acute, Pain, Chronic, Fractures, Closed, Fractures, Open

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Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)

Contact(s):

United Therapeutics Global Medical Information - clinicaltrials@unither.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05776225

Show full eligibility criteria

Interventions: PROCEDURE: Right heart catheterization (RHC)

Conditions: Interstitial Lung Disease, Pulmonary Hypertension

Keywords: ILD, PH, PH-ILD

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HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry (HF2 Registry)

Contact(s):

Kartik Munshi, MPH - kmunshi@kumc.edu

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years to 100 years old

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06425848

Show full eligibility criteria

Interventions: DEVICE: Observational

Conditions: Heart Failure

Keywords: Pulmonary Artery (PA) pressure monitor

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Strategy for Improving Stroke Treatment Response (SISTER)

Contact(s):

Reilly Leonard - reilly.leonard@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05948566

Show full eligibility criteria

Inclusion Criteria:

• Age 18 years and older
• Suspected anterior circulation acute ischemic stroke
• Presenting NIH Stroke Scale score \>/= 6
• Favorable baseline neuroimaging
• CT scan with ASPECTS of \>/=6, or MRI with ASPECTS of \>/=7 and
• CT or MR Perfusion with a mismatch ratio \>1.2 between the volume of hypoperfusion and the volume of the ischemic core, an absolute difference in volume \> 10 ml, and an ischemic-core volume of less than 70 ml. and
• Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well
• Informed consent for the study participation obtained from participant or their legally authorized representatives.

Exclusion Criteria:

• Patients planned to receive endovascular treatment.
• Patients that received or planned to receive intravenous thrombolysis.
• Pre-stroke modified Rankin score \>2.
• Known previous allergy to antibody therapy.
• Known pregnancy or positive urine or serum pregnancy test for women of child bearing potential.
• Known previous stroke in the past 90 days.
• Known previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
• Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
• Surgery or biopsy of parenchymal organ in the past 30 days.
• Known trauma with internal injuries or ulcerative wounds in the past 30 days.
• Severe head trauma in the past 90 days.
• Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management.
• Serious systemic hemorrhage in the past 30 days.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>1.7.
• Platelets \<100,000/mm3.
• Hematocrit \<25 %.
• Elevated PTT above laboratory upper limit of normal.
• Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
• Received heparin or low molecular weight heparins (such as dalteparin, enoxaparin, tinzaparin) in full dose within the previous 24 hours.
• Received Factor Xa inhibitors (such as fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
• Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
• Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
• Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
• Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
• Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.

Interventions: BIOLOGICAL: TS23

Conditions: Ischemic Stroke

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Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 2 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04759586

Show full eligibility criteria

Inclusion Criteria:

* Age \>= 2 years * Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma * Children's Oncology Group (COG) Institutions: Use Karnofsky for patients \>= 17 and \< 18 years of age and Lansky for patients \< 17 years of age * Adults (age 18 or older): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Pediatric Patients (age \< 18 years): The following must have been obtained within 14 days prior to registration: * Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2, or * Serum creatinine =\< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows: * Age : 2 to \< 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female) * Age : 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) * Age : 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) * Age : 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age : \>= 16 years to \< 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) * Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome * Age \>= 18 years: Ejection fraction of \>= 50% by echocardiogram * Age \< 18 years: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Administration of prior anti-cancer therapy except as outlined below: * A short course (=\< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms * A single course of COP (cyclophosphamide, vincristine, and prednisone) * One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131), or intrathecal chemotherapy that has not started more than 21 days prior to enrollment * Active ischemic heart disease or heart failure * Active uncontrolled infection * Central nervous system (CNS) involvement of lymphoma * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this trial * Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment * In patients \< 18 years of age hepatitis B serologies consistent with past or current infections * Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin \> 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert's syndrome * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of \< 1% per year when used consistently and correctly) for the duration of their study participation * Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography, DRUG: Etoposide Phosphate, BIOLOGICAL: Filgrastim, PROCEDURE: Lumbar Puncture, BIOLOGICAL: Nivolumab, BIOLOGICAL: Pegfilgrastim, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, RADIATION: Radiation Therapy, BIOLOGICAL: Rituximab, BIOLOGICAL: Rituximab and Hyaluronidase Human, DRUG: Vincristine Sulfate

Conditions: Primary Mediastinal Large B-Cell Lymphoma

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Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Contact(s):

Dana Sparks, MAT - dsparks@swog.org

Principal Investigator:

Principal Investigator ID:

Sex: MALE

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03678025

Show full eligibility criteria

Inclusion Criteria:

* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma\* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (\*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC). * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation). * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \[NaF\], prostate-specific membrane antigen \[PSMA\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \[FACBC\], carbon \[C\]11) but not conventional imaging (technetium \[Tc\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically. * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease. * STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer. * STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST. * STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization. * STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration. * STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded. * STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available. * STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. * STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies. * STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies. * STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system. * STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization. * STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization. * STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer. * STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization. * STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =\< grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) prior to randomization. * STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=\< 4 sites). All treatment must be completed prior to randomization. * STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization. * STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone \< 50 ng/dL within 28 days prior to randomization. * STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.

Interventions: DRUG: Abiraterone, DRUG: Bicalutamide, DRUG: Degarelix, DRUG: Docetaxel, DRUG: Flutamide, DRUG: Goserelin Acetate, DRUG: Histrelin Acetate, DRUG: Leuprolide Acetate, DRUG: Nilutamide, PROCEDURE: Orchiectomy, DRUG: Prednisone, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, PROCEDURE: Radical Prostatectomy, DRUG: Triptorelin

Conditions: Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

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Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors

Contact(s):

Kellogg Parsons, MD, M.H.S. - kparsons@mbracetrx.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06014658

Show full eligibility criteria

Inclusion Criteria:

• Provide written consent on an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
• 18 years of age or older at the time of informed consent.
• Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or practicing effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug. Female patients must be nonlactating and have a negative serum pregnancy test result at screening and baseline.
• Male patients must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) for the duration of study participation and for 6 months after the final dose of study drug.
• Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard of care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines. A. For Phase 1 dose escalation: histologic or cytologic diagnosis of malignant solid tumor of any type. The Sponsor may remove specific tumor indications based on emerging, real-time study data. B. For Phase 1b dose expansion: i. Cohort A: Histologic or cytologic diagnosis of NSLC (adenocarcinoma and SCC). ii. Cohort B: Histologic or cytologic diagnosis of TNBC or HR positive, HER2 negative breast cancer. iii. Cohort C: Histologic or cytologic diagnosis of the following advanced metastatic solid tumors refractory to standard treatment: pancreatic adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma, ovarian adenocarcinoma, and squamous cell carcinoma including, but not limited to, primary malignancies of the head and neck, esophagus, cervix, and skin. The Sponsor may add or remove specific tumor indications based on emerging, real-time study results.
• For Phase 1 and Phase 1b, availability of a tumor tissue sample (formalin-fixed paraffin embedded \[FFPE\]) must be confirmed for analysis of EphA5 expression based on IHC. Tumor biopsies are not required and should not be performed to assess eligibility. A. For Dose Escalation (Phase 1) and Dose Expansion (Phase 1b), tumor EphA5 expression will not be required for enrollment.
• For Dose Escalation (Phase 1), patients may have evaluable disease or measurable disease according to RECIST v1.1). For Dose Expansion (Phase 1b), patients must have measurable disease according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Life expectancy ≥ 3 months as assessed by the investigator.
• Hematologic function, as follows (no red blood cell \[RBC\] or platelet transfusions are allowed within 14 days of the first dose of MBRC-101): A. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L B. Platelet count ≥ 100 × 109/L C. Hemoglobin ≥ 9 g/dL
• eGFR ≥ 30 mL/min by the CKD-EPI or similar equation or as measured by 24 hour urine collection.
• Total bilirubin ≤ 1.5 × upper limit normal (ULN).
• AST ≤ 3.0 × ULN.
• ALT ≤ 3.0 × ULN.
• International normalised ratio (INR) \< 1.5 (or ≤ 3.0 if on therapeutic anticoagulation).
• Treatment with other agents for cancer, if received, must have been discontinued ≥ 2 weeks prior to first dose of study drug. Prior ADC therapy is allowed. Prior agents conjugated to MMAE are allowed for Phase 1 but not Phase 1b.

Exclusion Criteria:

• Preexisting sensory neuropathy Grade ≥ 2.
• Preexisting motor neuropathy Grade ≥ 2.
• Uncontrolled central nervous system metastases
• Use of any investigational drug within 14 days prior to the first dose of study drug.
• Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy, or any other agents to treat cancer (anti-hormonal therapy given for advanced prostate cancer or as adjuvant therapy for early stage, hormone receptor (HR) positive breast cancer is not considered cancer therapy for the purpose of this protocol).
• Patients with immunotherapy related AEs requiring high doses of steroids (≥ 40 mg/day of prednisone) are not eligible.
• Strong CYP3A or inducers within 14 days prior to the first dose of study drug.
• Thromboembolic events and/or bleeding disorders ≤ 14 days (e.g., venous thromboembolism \[VTE\] or pulmonary embolism \[or PE\]) prior to the first dose of study drug.
• Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class 3-4 within 6 months prior to the first dose of MBRC-101.
• A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) \> 470 msec.
• Human immunodeficiency virus (HIV) infection with 1 or more of the following: A. Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening; B. A change in antiretroviral therapy within 3 months of the start of screening and viral load \> 500 copies/mL; C. Receiving antiretroviral therapy that may interfere with study drug; D. CD4 count \< 350 at screening.
• Active or symptomatic viral hepatitis. Patients who have been properly treated for hepatitis C infection can be included if they do not have active hepatitis C.
• Known sensitivity to any of the ingredients of the investigational product MBRC-101.
• Major surgery within 28 days prior to first dose of study drug.
• History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Allowed exceptions are patients with: A. Non-melanoma skin cancer considered completely cured; B. Localized prostate cancer treated with curative intent with no evidence of progression; C. Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat; D. Malignancy that is otherwise considered cured with minimal risk of recurrence.
• Currently receiving systemic antimicrobial treatment for active infection (bacterial, viral, or fungal) at the time of first dose of MBRC-101. Routine antimicrobial prophylaxis is permitted.
• For Phase 1b dose expansion, prior ADC therapy is not allowed if the agent is conjugated to MMAE. Prior agents conjugated to MMAE are allowed for Phase 1.
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.
• Any medical, psychiatric, addictive, or other kind of disorder which compromises the ability of the patient to give written informed consent and/or to comply with procedures.
• Active ocular surface disease at baseline or any components of the ophthalmologic history which, in the investigator's opinion, may place the patient at significant risk.

Interventions: DRUG: Antibody-Drug Conjugate

Conditions: Cancer

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Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: Up to 30 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06172296

Show full eligibility criteria

Inclusion Criteria:

* Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131 * ≤ 30 years at the time of initial diagnosis with high-risk disease * Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines * Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following: * Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification * Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment) * Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy * Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment) * Patients must have a BSA ≥ 0.25 m\^2 * No prior anti-cancer therapy except as outlined below: * Patients initially recognized to have high-risk disease treated with topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing, and with consent * Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria * Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis * Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * A serum creatinine based on age/sex derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the CDC or * a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 or * a GFR ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard) Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age * Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \[ALT\]) ≤ 10 x ULN\* * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram * Ability to tolerate Peripheral Blood Stem Cell (PBSC) Collection: No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure

Exclusion Criteria:

* Patients who are 365-546 days of age with INRG Stage M and MYCN non amplified NBL, irrespective of additional biologic features * Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features * Patients with known bone marrow failure syndromes * Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable * Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, food and drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, BIOLOGICAL: Dinutuximab, DRUG: Doxorubicin, DRUG: Etoposide, PROCEDURE: FDG-Positron Emission Tomography and Computed Tomography Scan, PROCEDURE: Hematopoietic Cell Transplantation, DRUG: Irinotecan, DRUG: Isotretinoin, PROCEDURE: Leukapheresis, PROCEDURE: Magnetic Resonance Imaging, DRUG: Melphalan, RADIATION: Radiation Therapy, PROCEDURE: Radionuclide Imaging, OTHER: Survey Administration, DRUG: Temozolomide, DRUG: Thiotepa, DRUG: Topotecan, PROCEDURE: Tumor Resection, DRUG: Vincristine

Conditions: Ganglioneuroblastoma, Nodular, Neuroblastoma

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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Contact(s):

Keera McKenna - keera.mckenna2@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05943535

Show full eligibility criteria

Inclusion Criteria:

• Subject gives voluntary informed consent to participate in the study.
• Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
• Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
• Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:
• Clinically significant decline in % predicted FVC based on ≥10% relative decline
• Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
• Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
• Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
• FVC ≥45% predicted at Screening (confirmed by central review).
• Subjects must be on 1 of the following:
• On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
• Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study. Concomitant use of both nintedanib and pirfenidone is not permitted.
• Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.
• Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:
• Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
• Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential.
• Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
• In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion Criteria:

• Subject is pregnant or lactating.
• Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
• Subject has a diagnosis of IPF.
• Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
• Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments.
• Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
• Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
• Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
• Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
• Acute pulmonary embolism within 90 days prior to Baseline.
• In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
• In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.

Interventions: DRUG: Placebo, DRUG: Inhaled Treprostinil, DEVICE: Treprostinil Ultrasonic Nebulizer

Conditions: Progressive Pulmonary Fibrosis, Interstitial Lung Disease

Keywords: Treprostinil, PPF, ILD

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A Study of ASP1002 in Adults for Treatment of Solid Tumors

Contact(s):

Astellas Pharma Global Development, Inc. - Astellas.registration@astellas.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE1

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05719558

Show full eligibility criteria

Inclusion Criteria:

* Participant has locally-advanced (unresectable) or metastatic solid tumor which is confirmed by available pathology records or current biopsy. * For dose escalation, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is exclusionary): a. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require medical monitor consultation prior to study entry; b. urothelial carcinoma (UC); c. colorectal cancer (CRC); d. Prostate adenocarcinoma; e. Ovarian cancer; f. triple-negative breast cancer (TNBC): TNBC defined as unequivocal TNBC histology (estrogen receptor-1 (ER-1) negative/progesterone receptor-negative/ human epidermal growth factor receptor (HER2)-negative). This is defined by \< 1% expression of ER and progesterone receptor by immunohistochemistry (IHC) and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative (not amplified) as per current American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines \[Hammond et al, 2010\]. * For dose expansion, the participant must have one of the following malignancies (for all tumor types, any component of neuroendocrine histology is not eligible): a. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require medical monitor consultation prior to study entry; b. UC; c. CRC; d. Tumor type for which a confirmed response was observed during dose escalation. * Participant has progressed, is intolerant, has refused, or there are no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens). * Participant has accessible archival tumor tissue (\< 6 months old) from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study intervention; participants without available tissue should undergo a mandatory biopsy. If the participant is unable to undergo a biopsy due to safety concerns, enrollment into the study is at the discretion of the medical monitor. Participant should undergo a tumor biopsy during the treatment period as indicated in the schedule of assessments. Note: Tumor tissue collection (at screening/baseline and on-treatment) is optional for participants enrolled initially in dose levels 1 to 3 in dose escalation; however, protocol de-escalation and expansion of dose levels similar to dose levels 1 to 3 may require collection and processing of screening/baseline and on-treatment tumor samples. * Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1. * Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to study intervention administration. * Participant has predicted life expectancy \>/= 12 weeks. * Participant has adequate organ function prior to start of study intervention. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>/=2 weeks after any blood transfusion. * Female participant is not pregnant and at least 1 of the following conditions apply: * a. Not a woman of childbearing potential (WOCBP) * b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration. * Female participant must agree not to breastfeed starting at screening and throughout the study period and for 90 days after final study intervention administration. * Female participant must not donate ova starting at first administration of study intervention and throughout 90 days after final study intervention administration. * Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 90 days after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 90 days after final study intervention administration. * Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 90 days after final study intervention administration. * Participant agrees not to participate in another interventional study while receiving study intervention in the present study.

Exclusion Criteria:

* Participant weighs \< 40 kg. * Participant has ongoing toxicity \>/= grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior antineoplastic therapies. * Participant has untreated or active central nervous system (CNS) metastases. Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (equivalent to \> 10 mg per day of prednisone) for longer than 2 weeks. * Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed. * Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block). * Participant has a corrected corrected QT interval (QTcF) interval (single electrocardiogram (ECG)) \> 470 ms within 7 days prior to the first study intervention administration on day 1. * Participant has left ventricular ejection fraction (LVEF) \< 45% noted in screening echocardiogram (ECHO). Any clinically significant findings from this ECHO should be discussed with the medical monitor. * Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with HIV infection with CD4+ T cell counts \>/=350 cells/μL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. Note: No HIV testing is required at screening unless mandated per local requirements. * Participant has any of the following per screening serology test: * a. Hepatitis A virus antibodies immunoglobulin (IgM) * b. Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B Deoxyribonucleic Acid (DNA). Participant with negative HBsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable * c. hepatitis C virus (HCV) antibodies unless HCV Ribonucleic acid (RNA) is undetectable * Participant has a history of drug-induced pneumonitis, interstitial lung disease (ILD), currently has pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids. * Participant has an infection requiring intravenous antibiotics within 14 days prior to study intervention administration. * Participant has received a prior allogeneic bone marrow or solid organ transplant. * Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study intervention. * Participant with recent positive antigen test for Coronavirus Disease 2019 (COVID-19) within 10 days prior to study intervention administration. Note: Participants who are asymptomatic after 10 days from the first positive antigen test may be enrolled. * Participant has received any investigational therapy or antineoplastic therapy or other immunotherapy within 21 days or 5 half-lives, whichever is shorter, prior to the first dose of study intervention. Note: Participants with prostate adenocarcinoma who do not have a bilateral orchiectomy should continue androgen deprivation therapy (ADT) during the study. A participant with epidermal growth factor receptor (EGFR), receptor tyrosine kinase (encoded by the gene ROS1), or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine receptor inhibitor, neurotrophic tyrosine receptor kinase inhibitor or ALK inhibitor therapy until 4 days prior to the start of study intervention administration. * Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to ASP1002 administration. Participants using a physiologic replacement dose of corticosteroids equivalent to 10 mg per day of prednisone or less are allowed, as is receiving a single dose of systemic corticosteroids, or receiving systemic corticosteroids as premedication for radiologic imaging contrast is eligible. * Participant was discontinued from prior immunomodulatory therapy due to a grade \>/=3 toxicity that was mechanistically related (e.g., immune-related) to the agent and deemed life-threatening. * Participant is expected to require another form of antineoplastic therapy while on study intervention. * Participant has another malignancy requiring active therapy; (other than those indicated in Inclusion Criterion No. 1). * Participants who have received prior anti-CD137 therapy. * Participant has received a live vaccine against infectious diseases within 28 days prior to initiation of study intervention. * Participant has any condition makes the participant unsuitable for study participation. * Participant has a known or suspected hypersensitivity to ASP1002 or any components of the formulation used.

Interventions: DRUG: ASP1002

Conditions: Advanced Solid Tumors

Keywords: Solid Tumor,, Malignancy,, Metastasis,, cancer,, ASP1002,, Pharmacokinetics

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Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation (JANUS)

Contact(s):

J. Joshua Smith, MD - smithj5@mskcc.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE2

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05610163

Show full eligibility criteria

Inclusion Criteria:

* Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis * Tumor site: Rectum; =\< 12cm from the anal verge * No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects \* Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =\< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for \>= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for \>= 6 months after the last treatment * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%) * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm * Creatinine =\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \>= 50 mL/min \^3 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) * No upper rectal tumors (distal margin of tumor \> 12 cm from the anal verge) * No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis * No known mismatch repair deficient rectal adenocarcinoma * Human immunodeficiency virus HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study \* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Interventions: DRUG: Capecitabine, DRUG: 5-fluorouracil, DRUG: Leucovorin calcium, DRUG: Irinotecan, DRUG: Oxaliplatin, RADIATION: Long Course Chemoradiotherapy, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Sigmoidoscopy, PROCEDURE: biopsy

Conditions: Locally Advanced Rectal Carcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

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Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Contact(s):

Anne Beaven, MD - anne_beaven@med.unc.edu

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 60 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05976763

Show full eligibility criteria

Inclusion Criteria:

* • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center * Any stage allowed (stage I-IV) * Presence of measurable disease, defined as \>= 1 nodal lesion that is \> 1.5 cm in longest diameter or \>= 1 extranodal lesion that is \> 1 cm in longest diameter * Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days * No prior systemic treatment for mantle cell lymphoma * No prior radiation treatment for stage I MCL * No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody * No prior stem cell transplant * Age \>= 70 years OR age \>= 60 to \< 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \< 45%, b) diffusing capacity for carbon monoxide \< 60% predicted; c) creatinine clearance \< 70 but \> 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \> 6 * ECOG Performance Status 0-2 * Absolute neutrophil count (ANC) \>= 750/mm\^3 (without growth factor support within 7 days) * Platelet count \>= 75,000/mm\^3 (or \>= 50,000/mm\^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days * Creatinine clearance \>= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome) * Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN * Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy * No clinically significant cardiovascular disease including the following * Unstable angina within 3 months before registration * New York Heart Association class III or IV congestive heart failure * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) * QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * No history of stroke or intracranial hemorrhage within 6 months prior to registration * No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills * Potential trial participants should have recovered from major surgery * No vaccination with a live vaccine within 35 days prior to registration * No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment * Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers * Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional

Interventions: DRUG: Zanubrutinib, BIOLOGICAL: Rituximab, OTHER: Patient Observation, PROCEDURE: Bone Marrow Biopsy, OTHER: Fludeoxyglucose F-18, PROCEDURE: Positron Emission Tomography, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Esophagogastroduodenoscopy, PROCEDURE: Colonoscopy, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration

Conditions: Mantle Cell Lymphoma

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INSPIRE Pipeline™ Shield Post Approval Study

Contact(s):

Medtronic Neurovascular Clinical Affairs - rs.shieldpostapproval@medtronic.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 22 years and over

Phase:

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05071963

Show full eligibility criteria

Interventions: DEVICE: Treatment of Intracranial Aneurysms

Conditions: Intracranial Aneurysm

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Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Contact(s):

Jennifer Salazar - jennifer.salazar@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT03926624

Show full eligibility criteria

Inclusion Criteria:

• Histologically or pathologically confirmed diagnosis of AML based on WHO classification that has relapsed after, or is refractory to, two, three, or four prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), or targeted therapy (e.g., FLT-3, IDH-1/2, BCL-2, monoclonal antibody). (Relapse is defined as reemergence of ≥5% leukemia blasts in bone marrow or ≥1% blasts in peripheral blood ≥90 days after first CR or CR without complete platelet recovery (CRp). Refractory AML is defined as persistent disease ≥28 days after initiation of intensive induction therapy (up to two induction cycles) or relapse \<90 days after first CR or CRp. Refractory disease for patients undergoing hypomethylating agent induction is defined as lack of remission following at least 2 cycles of epigenetic therapy without reduction in bone marrow blast status.) Patients with a history of IPSS-R high or very high risk MDS that transformed to AML during treatment with hypomethylating drugs and then relapse following or are refractory to a subsequent AML induction regimen may be enrolled as Second Salvage AML patients. Additionally, patients with a history of MPN in accelerated phase (MPN-AP) or high-risk primary myelofibrosis (PMF) that transformed to AML during treatment with hypomethylating drugs and then relapse following or are refractory to a subsequent AML induction regimen may be enrolled as Second Salvage AML patients.
• Aged ≥ 18 years.
• ECOG Performance Status of 0, 1 or 2.
• Adequate clinical laboratory values (i.e., plasma creatinine \<2.5 x upper limit of normal (ULN) for the institution, bilirubin \<2.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN).
• Absence of active central nervous system (CNS) involvement by leukemia. Patients with previously diagnosed CNS leukemia are eligible if the CNS leukemia is under control and intrathecal treatment may continue throughout the study.
• Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
• Signed informed consent prior to the start of any study specific procedures.
• Women of child-bearing potential must have a negative serum or urine pregnancy test.
• Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.

Exclusion Criteria:

• The interval from prior treatment to time of study drug administration is \< 2 weeks for cytotoxic agents or \< 5 half-lives for noncytotoxic agents. Exceptions: Use of hydroxyurea is allowed before the start of study and is to be discontinued prior to the initiation of study treatment. At the investigator's discretion, for patients with significant leukocytosis that develops during the early treatment cycles, hydroxyurea may be administered. The hydroxyurea should be discontinued as soon as clinically appropriate.
• Any \>grade 1 persistent clinically significant toxicities from prior chemotherapy.
• Inadequate Cardiac (left ventricular ejection fraction ≤40%) function.
• White blood cell (WBC) count \>15,000/μL (Note: Patients considered for possible venetoclax-containing regimen must have WBC ≤10k/μL prior to initiating venetoclax treatment).
• For patients with prior hematopoietic stem cell transplant (HSCT):
• Less than 3 months since HSCT
• Acute Graft versus Host Disease (GvHD) \>Grade 1
• Chronic GvHD \>Grade 1
• Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
• A pregnant or lactating woman.
• Current malignancies of another type. Exceptions: Patients may participate if they have previously treated and currently controlled prostate cancer, or adequately treated in situ cervical cancer or basal cell skin cancer, or other malignancies with no evidence of disease for 2 years or more.
• Patient has acute promyelocytic leukemia (APL).
• Patients with known HIV, active HBV or active HCV infection (note: testing for these infections is not required). For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Documented or known clinically significant bleeding disorder.

Interventions: DRUG: DFP-10917, DRUG: Cytarabine, DRUG: Azacitidine, DRUG: Decitabine, DRUG: Mitoxantrone, DRUG: Etoposide, DRUG: Fludarabine, DRUG: Idarubicin, DRUG: Venetoclax, DRUG: Cladribine

Conditions: Leukemia, Myeloid, Acute

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Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial (MAFASA)

Contact(s):

Katy Feeny - kfeeny@sonavex.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years to 84 years old

Phase: NA

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06190717

Show full eligibility criteria

Inclusion Criteria:

* Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent. * Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures. * Subject is willing and capable of complying with all required follow-up visits. * Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance. * Subject has an estimated life expectancy \> 18 months. * Subject is ambulatory (cane or walker are acceptable). * CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access. * Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR \<10). * Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping. * Artery diameter ≥ 2.5 mm per vein mapping. * Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.

Exclusion Criteria:

* CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access. * Subject has history of Steal Syndrome. * Subject who is immunocompromised or immunosuppressed. * Subject has had three previous failed AV fistulae for hemodialysis access. * Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation. * Known or suspected active infection on the day of the index procedure. * Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula. * Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access. * Subjects with active malignancy. * Subjects with a history of poor compliance with the dialysis protocol. * Subjects with a known or suspected allergy to any of the device materials. * Subjects with an existing fistula or graft. * Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months. * Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.

Interventions: DEVICE: EchoMark/EchoSure, PROCEDURE: Standard of Care

Conditions: Diabetes, End Stage Renal Disease

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Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)

Contact(s):

Katie Keck, MD - keckkt@gmail.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 4 years to 7 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT06380517

Show full eligibility criteria

At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.
• Age 4 to 7 years.
• Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
• VA in the amblyopic eye 20/40 to 20/200 inclusive.
• Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
• Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
• Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below). * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
• Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent (SE). * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is met (see above). * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes.
• No more than 2 weeks (cumulative) of prior dichoptic treatment.
• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
• Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
• Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
• Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated.
• Participant is willing to wear the Luminopia headset.
• Participant is willing to continue full-time spectacles/contact lens wear (if needed).
• Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.
• Interpupillary distance of 52mm to 72mm inclusive.
• Investigator is willing to prescribe Luminopia or patching per protocol.
• Parent understands the protocol and is willing to accept randomization.
• Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.
• Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated. Individuals meeting any of the following criteria will be excluded from study participation.
• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
• Prism lenses or need of a prism prescription at enrollment.
• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00D spherical equivalent in either eye.
• Previous intraocular or refractive surgery.
• Known skin reactions to patch or bandage adhesives.
• Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
• Diplopia more than once per week over the last week prior to enrollment by parental report.
• History of light-induced seizures.
• Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
• Participation in a prior study involving patching for amblyopia
• Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.

Interventions: DEVICE: Luminopia, OTHER: Eye Patch

Conditions: Amblyopia

Keywords: Dichoptic, Luminopia, Patching, movie

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Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Contact(s):

Jocelyn Tabora - jtabora@ardelyx.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 12 years to 17 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05643534

Show full eligibility criteria

Inclusion Criteria:

* ≥12 and \<18 years old * Patient weighs ≥18 kg at the time the patient provides written assent * Females of child-bearing potential must have negative pregnancy test at Visit 1 (serum) and Visit 2 (urine) and confirm the use of appropriate contraception (including abstinence). * Patient meets the Rome IV criteria for child/adolescent diagnosis of IBS-C * Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement) * Patient meets the entry criteria assessed during the 2-week Screening period. * Ability of both the patient and parent/guardian/LAR to communicate with the Investigator and to comply with the requirements of the entire study, including an understanding of the assessments in the eDiary and how to use the eDiary device * Patient must provide written assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures

Exclusion Criteria:

* Functional diarrhea as defined by Rome IV child/adolescent criteria * IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV child/adolescent criteria * History of non-retentive fecal incontinence. * Required manual disimpaction any time prior to randomization (after consent); * Has both unexplained and clinically significant alarm symptoms (lower gastrointestinal \[GI\] bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process * Patient has any of the following conditions: * Celiac disease, or positive serological test for celiac disease * Cystic fibrosis * Hypothyroidism that is untreated or treated with thyroid hormone * Down's syndrome or any other chromosomal disorder * Active anal fissure * Anatomic malformations (eg, imperforate anus) * Intestinal nerve or muscle disorders (eg, Hirschprung disease) * Neuropathic conditions (eg, spinal cord abnormalities) * Lead toxicity, hypercalcemia * Neurodevelopmental disabilities producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device) * Inflammatory bowel disease * Childhood functional abdominal pain syndrome * Childhood functional abdominal pain; * Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; * Lactose intolerance that is associated with abdominal pain or discomfort * History of cancer other than treated basal cell carcinoma of the skin; (Note: Patients with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit.) * History of diabetic neuropathy. * Use of medications that are known to affect stool consistency (Prohibited Medications), including fiber supplements, anti-diarrheals, cathartics, antacids, opiates, prokinetic drugs, laxatives, enemas, antibiotics during the Screening period; unless specified as rescue medication, and used accordingly as directed by the Investigator. * Patient has had surgery that meets any of the following criteria: * Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit; * Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit; * An appendectomy or cholecystectomy during the 60 days before the Screening Visit; * Other major surgery during the 30 days before the Screening Visit * History of alcohol or substance abuse * Participation in other clinical trials within 1 month prior to Screening * Patient and/or parent/guardian/LAR is involved in the conduct and/or administration of this trial as an investigator, sub-investigator, trial coordinator, or other staff member, or the patient is a first-degree family member, significant other, or relative residing with one of the above persons involved in the trial * If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition, which would render the results uninterpretable

Interventions: DRUG: Tenapanor 50 MG, DRUG: Tenapanor 25 mg bid, DRUG: Placebo

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Keywords: IBS-C

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A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Contact(s):

IRB@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 2 years to 25 years old

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04576117

Show full eligibility criteria

Inclusion Criteria:

* Feasibility phase: patients must be \>= 2 years and =\< 21 years of age at the time of enrollment * Efficacy phase: patients must be \>= 2 years and =\< 25 years of age at the time of enrollment * All patients \> 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age * Patients must have a body surface area (BSA) of \>= 0.5 m\^2 at enrollment * Patients must have eligibility confirmed by rapid central pathology and central molecular screening reviews performed on APEC14B1 * Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation * Patients must have progressive or recurrent LGG. Note: Biopsy may be at either initial diagnosis or recurrence * Patients must have measurable disease, defined as having a two-dimensional measurable tumor volume of \>= 1 cm\^2 * Tumor size will be measured to include both solid and cystic components of the tumor (whether or not tumor is enhancing) + fluid attenuated inversion recovery (FLAIR) signal * Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization \[WHO\] grade 1 and II) by the WHO Classification of Tumors of the Central Nervous System - 4th Edition Revised, with the exception of subependymal giant cell astrocytoma * Patients with metastatic disease or multiple independent primary LGGs are eligible * Patients must be progressive or recurrent after having been treated with at least one prior tumor-directed therapy before enrollment * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea); * Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; * Radiation therapy (RT): \>= 2 weeks (wks) for local palliative RT (small port); \>= 6 months must have elapsed if prior craniospinal RT or if \>= 50% radiation of pelvis; \>= 6 wks must have elapsed if other substantial bone marrow (BM) radiation; * Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to =\< grade 1; * MEK inhibitor or vinblastine: Must not have received treatment with a MEK inhibitor or vinblastine within 6 months of study enrollment * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^ 2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): * 2 to \< 6 years: 0.8 mg/dL (male) 0.8 mg/dL (female) * 6 to \< 10 years: 1 mg/dL (male) 1 mg/dL (female) * 10 to \< 13 years: 1.2 mg/dL (male) 1.2 mg/dL (female) * 13 to \< 16 years: 1.5 mg/dL (male) 1.4 mg/dL (female) * \>= 16 years: 1.7 mg/dL (male) 1.4 mg/dL (female) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect \[unconjugated\] bilirubin levels as long as their direct \[conjugated\] bilirubin is \< 3.1 mg/dL) * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Albumin \>= 2 g/L (within 7 days prior to enrollment) * Left ventricular ejection fraction (LVEF) \>= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment) * Corrected QT interval (QTc interval) =\< 450 msec by electrocardiogram (EKG) (within 4 weeks prior to enrollment) * Absolute neutrophil count \>= 1,000/uL (unsupported) (within 7 days prior to enrollment) * Platelets \>= 100,000/uL (unsupported) (within 7 days prior to enrollment) * Hemoglobin \>= 8 g/dL (may be supported) (within 7 days prior to enrollment) * Patients with a known seizure disorder should be stable and should not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment * Stable neurological examination for \>= 1 week * HYPERTENSION: * Patients 2-17 years of age must have a blood pressure that is =\< 95th percentile for age, height, and gender at the time of enrollment (with or without the use of anti-hypertensive medications); * Patients \>= 18 years of age must have a blood pressure =\< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications) * Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension * All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment * For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site\[s\] of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment * Note: If surgical resection or biopsy is performed at the time of progression or recurrence, a post-operative MRI is required * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Patients must have the ability to swallow whole capsules

Exclusion Criteria:

* Prior therapy with vinblastine and/or a MEK inhibitor is permitted, with the following exceptions: * Patients must not have had progressive disease while on therapy with vinblastine or a MEK inhibitor; * Patients must not have discontinued vinblastine or selumetinib due to toxicity * Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible * Patients with diffuse intrinsic pontine tumors as seen on MRI (\> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology * Patients may not be receiving any other investigational agents * Patients must not have known hypersensitivity to selumetinib, vinblastine, or similar compounds * CYP3A4 agents: Patients must not have received fluconazole or drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment * Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment * Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible * PRE-EXISTING CONDITIONS (CARDIAC): * Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented; * Symptomatic heart failure * New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy * Severe valvular heart disease * History of atrial fibrillation * PRE-EXISTING CONDITIONS (OPHTHALMOLOGIC CONDITIONS): * Current or past history of central serous retinopathy * Current or past history of retinal vein occlusion or retinal detachment * Patients with uncontrolled glaucoma * If checking pressure is clinically indicated, patients with intraocular pressure (IOP) \> 22 mmHg or upper limit of normal (ULN) adjusted by age are not eligible * Any multivitamin containing vitamin E must be stopped prior to study enrollment even if it contains less than 100% of the daily recommended dosing for vitamin E * Surgery within 2 weeks prior to enrollment, with the exception of a surgical biopsy, placement of a vascular access device or cerebrospinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt * Note: Patients must have healed from any prior surgery * Patients who have an uncontrolled infection are not eligible * Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible * Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Selumetinib Sulfate, DRUG: Vinblastine Sulfate

Conditions: Recurrent Low Grade Astrocytoma, Recurrent WHO Grade 2 Glioma, Refractory Low Grade Astrocytoma, Refractory Low Grade Glioma, Refractory WHO Grade 1 Glioma

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A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE (LIBREXIA-STROK)

Contact(s):

Study Contact - Participate-In-This-Study@its.jnj.com

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 40 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05702034

Show full eligibility criteria

Inclusion Criteria:

* Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (\<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (\>=) 6 * Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event. * Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care * A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention * Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (\>) 1 year prior with adequate treatment * The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation * The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial \[TOAST\] Other Determined Etiology), based on local standard-of-care investigations * Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage * Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis * Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

Interventions: DRUG: Milvexian, DRUG: Placebo

Conditions: Ischemic Stroke, Ischemic Attack, Transient

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T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Contact(s):

Ciara C. O'Sullivan, MB, BCh, BAO - osullivan.ciara@mayo.edu

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 18 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT04457596

Show full eligibility criteria

Inclusion Criteria:

* HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required \* Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR * Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible) * Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients * Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report * The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis \* Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not * Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive * Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable * Prior receipt of T-DM1 in the neoadjuvant setting is not allowed. * Prior treatment must have consisted of \>= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of \>= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration \[FDA\]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received \>= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed. * Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a \[trastuzumab deruxtecan\]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib). * Patients may have received =\< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =\< 5 weeks prior to registration \* Note: Both of the following two criteria need to be met for the patient to be eligible for this study * An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment * Patients must be registered on study within =\< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery) * All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response \[pCR\]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of \>= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants * Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =\< grade 1 * Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows: * Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision * For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection * Lymph node surgery \*\* The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Hemoglobin \>= 8 g/dL (Note: packed red blood cells \[PRBC\] transfusion is not permitted to achieve eligibility) * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) * Total bilirubin =\< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Screening left ventricular ejection fraction (LVEF) \>= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be \>= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility

Exclusion Criteria:

* No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =\< 7 days prior to registration is required * Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met * Stage IV (metastatic) breast cancer * History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration * Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report * Evidence of recurrent disease following preoperative therapy and surgery * Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation) * History of exposure to the following cumulative doses of anthracyclines: doxorubicin \> 240 mg/m\^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) \> 480 mg/m\^2. For other anthracyclines, exposure equivalent to doxorubicin \> 240 mg/m\^2 * Cardiopulmonary dysfunction as defined by any of the following: * History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade \>= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class \>= II * Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease * High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 \[Mobitz 2\] or third degree AV-block) * Significant symptoms (grade \>= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy * History of a decrease in left ventricular ejection fraction (LVEF) to \< 40% with prior trastuzumab treatment (e.g., during preoperative therapy) * Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) * Current severe, uncontrolled systemic disease * Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment * History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product * Peripheral neuropathy of any etiology that exceeds grade 1 * Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol * Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited. * Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

Interventions: BIOLOGICAL: Trastuzumab Emtansine, DRUG: Placebo Administration, DRUG: Tucatinib, OTHER: Questionnaire Administration, OTHER: Quality-of-Life Assessment

Conditions: HER2 Positive Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Multifocal Breast Carcinoma, Prognostic Stage IA Breast Cancer AJCC v8, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Synchronous Bilateral Breast Carcinoma

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Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) (SIRIUS-SLE 1)

Contact(s):

Laketa Hillman-Daughety - laketa.hillman-daughety@prismahealth.org

Principal Investigator:

Principal Investigator ID:

Sex: ALL

Age: 12 years and over

Phase: PHASE3

Healthy Volunteers:

This study is NOT accepting healthy volunteers

System ID: NCT05639114

Show full eligibility criteria

Inclusion Criteria:

* Male and female participants aged 12 years or older at the time of screening, or limited to 18 years or older in European Economic Area countries and other countries where inclusion of participants below 18 years is not allowed. * Diagnosis of systemic lupus erythematosus meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria at least 6 months prior to screening. * Elevated serum titers at screening of anti-nuclear antibodies ≥ 1:80 as determined by a central laboratory with a SLE-typical fluorescence pattern. * Currently receiving CS and/or anti-malarial treatment and/or another disease-modifying antirheumatic drug (DMARD) as specified in the protocol. * SLEDAI-2K criteria at screening: SLEDAI-2K score ≥ 6 points, excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome" * BILAG-2004 disease activity level at screening of at least 1 of the following: * BILAG-2004 level 'A' disease in ≥ 1 organ system, Or * BILAG-2004 level 'B' disease in ≥ 2 organ systems * Weigh at least 35 kg at screening

Exclusion Criteria:

* Prior treatment with ianalumab * History of receiving following treatment: I) high dose CS, calcineurin inhibitors, JAK or other kinase inhibitors or other DMARD (except as listed in inclusion criteria) administered within 12 weeks prior to screening. II) cyclophosphamide or biologics such as immunoglobulins (intravenous or s.c.), plasmapheresis, anti-type I interferon receptor biologic agents, anti-CD40 agents, CTLA4-Fc Ig or B-cell activating factor (BAFF)-targeting agents administered within 24 weeks prior to screening; belimumab administered within 12 weeks prior to screening. III) any B cell-depleting therapies, other than ianalumab administered within 36 weeks prior to randomization or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower). IV) Traditional Chinese medicines administered within 30 days prior to randomization. * Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection * Chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) * Evidence of active tuberculosis infection * History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result at screening * Any one of the following abnormal laboratory values prior to randomization * Platelets \< 25000/mm\^3 (\< 25 x 10\^3/μL) * Hemoglobin (Hgb) \< 8.0 g/dL (\< 5 mmol/L), or \< 7.0 g/dL (\< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia * Absolute neutrophil count (ANC) (\< 0.8 x 10\^3/ μL) * Severe organ dysfunction or life-threatening disease at screening * Presence of severe lupus kidney disease as defined by proteinuria above 2 g/day or equivalent using spot urine protein creatinine ratio, or serum creatinine greater than 2.0 mg/dL (176.84 µmol/L), or requiring immune-suppressive induction or maintenance treatment at screening * Receipt of live/attenuated vaccine within a 4-week period before first dosing * Any uncontrolled, co-existing serious disease, which in the opinion of the investigator will place the participant at risk for participation or interfere with evaluation for SLE-related symptoms * Non-lupus conditions such as asthma, gout or urticaria, requiring intermittent or chronic treatment with systemic CS * History of malignancy of any organ system other than localized basal cell carcinoma of the skin or in situ cervical cancer * Pregnant or nursing (lactating) women. * Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational drug. * Any surgical, medical, psychiatric or additional physical condition that may jeopardize participation in this study

Interventions: DRUG: Ianalumab, DRUG: Placebo

Conditions: Systemic Lupus Erythematosus

Keywords: Systemic Lupus Erythematosus, SLE, B cell depletion, SLEDAI-2K, BILAG-2004, SRI, ANA

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Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) (SIRIUS-SLE 1)

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