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162 Study Matches
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Angie Lee - alee@vertosmed.com
ALL
18 years and over
NCT03072927
Inclusion Criteria:
* Medicare beneficiaries receiving MILD or interspinous process decompression
* Diagnosis of LSS with NC
Exclusion Criteria:
* Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date DEVICE: MILD, DEVICE: Interspinous Process Decompression
Lumbar Spinal Stenosis
Lumbar Spinal Stenosis, Interspinous process decompression, MILD, Medicare, Medicare Advantage
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (FORTE)
Director, Department of Regulatory Affairs - langerj@nrgoncology.org
ALL
50 years to 70 years old
NA
NCT05080673
Inclusion Criteria:
* • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
* Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization.
* Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.
* Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.
* Complete excision of all observed polyps in qualifying colonoscopy
* Participants must be able to read or understand English or Spanish.
Exclusion Criteria:
* • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.
* Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.
* Traditional serrated adenomas found on the qualifying colonoscopy.
* Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.
* Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.
* Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
* Incomplete qualifying colonoscopy (e.g., cecum not visualized).
* Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)
* Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)
* Family history of CRC diagnosed at greater than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.
* Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]).
* Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer.
* Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
* Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.
* Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up. PROCEDURE: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)
Quill Turk, DO - Quill.Turk@prismahealth.org
ALL
18 years and over
PHASE2
NCT04167527
Inclusion Criteria:
• Age 18 years or older
• Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of an objective neurological deficit
• Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset
• Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showing complete occlusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with or without tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are defined functionally for the trial as following:
• On CTA: Occlusion of both branches after MCA division (both M2s occluded) or occlusion of the larger diameter M2 branch . In case of trifurcations, either the two largest M2 branches are occluded or the occluded M2 has a larger diameter than the combined diameter of the two other M2s . Notably, the M2 origins are defined by the first branching point in the MCA other than the anterior temporal artery rather than by anatomic landmarks (e.g., horizontal versus insular location). or
• If mCTA or CTP performed (optional): a M2 occlusion which supplies a large proportion of the MCA territory by evidence of either: i. The bulk (\>2/3) of the MCA territory has evidence of delayed washout on multiphase CT or ii. Perfusion imaging shows a hypoperfusion lesion volume involving a significant proportion of the MCA territory defined as Tmax \>4 sec lesion of ≥100 mL
• Baseline Infarct Core of either:
• Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
• Baseline Infarct Core Volume of \< 70cc on either CTP (Volume of rCBF \<30%) or DWI if quantitative software tools are available (neither test is mandatory for study)
Exclusion Criteria:
• NIHSS ≥6
• Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
• Any imaging findings suggestive of futile recanalization in the judgment of the local investigator
• High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD
• Premorbid disability (mRS ≥3)
• Inability to randomize within 8 hours of last known well
• Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
• Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol)
• Known coagulation disorders as defined as platelet count \<100,000/uL
• Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL
• Presumed septic embolus or suspicion of bacterial endocarditis
• Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
• Participation in another investigational treatment study in the previous 30 days
• Intubation and mechanical ventilation prior to study enrollment is medically indicated
• History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)
• Known pregnancy
• Prisoner or incarceration
• Known acute symptomatic COVID-19 infection
DEVICE: Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device, COMBINATION_PRODUCT: Initial medical management (iMM)
Cerebral Ischemia
Immediate Mechanical Thrombectomy, Initial medical management, Large vessel occlusion, Efficacy, Safety
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
18 years and over
PHASE2
NCT05040360
Inclusion Criteria:
* Participants must have a histologic diagnosis of well-differentiated pancreatic neuroendocrine tumor (pNET) that was resected between 14 and 90 days prior to registration. Participants must have a scan within 90 days prior to registration without evidence of metastatic disease. Acceptable scans are multiphase computed tomography (CT) abdomen, magnetic resonance imaging (MRI) with intravenous (IV) contrast of the abdomen, or positron emission tomography (PET)-CT DOTATATE imaging if the DOTATATE PET-CT included IV iodine contrast for the CT portion of the exam
* Resection must have been an R0 or R1 per treating investigator's assessment and/or pathology report
* Ki-67 testing, which is considered part of standard of care in the pathology report, must have been performed between 14 and 90 days prior to registration and the result must be \>= 3% and =\< 55%. Treating investigators are encouraged to contact the S2104 Study Chairs and/or the study pathology chair with questions. If more than one Ki-67 is reported (e.g., primary tumor versus lymph node or metastatic site), the highest one should be considered for the study eligibility criteria
* Participants with localized resected pNETS must have a Zaidi score of \>= 3 derived by the following factors and points:
* 1 point; symptomatic tumor defined as one of the following:
* Gastrointestinal bleed
* Jaundice
* Gastrointestinal obstruction
* Pain from primary tumor prior to surgical resection
* Pancreatitis
* 2 points; primary pancreas tumor size \> 2 cm
* 1 point; Ki-67 3% to 20%
* 1 point; lymph node positivity = 1
* 6 points; Ki-67 21% to 55%
* Participants may have received resection/ablation of liver oligo-metastatic disease (up to 5 liver metastases) at the time of well-differentiated pNET resection
* Participants must have recovered from effects of surgery as determined by the treating investigator
* Participants must be \>= 18 years old
* Participants must have Zubrod performance status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets \>= 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin =\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional ULN (within 28 days prior to registration)
* Serum creatinine =\< 1.5 x institutional ULN (within 28 days prior to registration)
* Calculated creatinine clearance \>= 50 ml/min (within 28 days prior to registration)
* Participants must be able to swallow pills
* Participants must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol
* No other active malignancy or history of prior malignancy is allowed, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
Exclusion Criteria:
* Participants must not have unresected or unablated metastatic disease
* Participants must not have clinically apparent central nervous system metastases or carcinomatous meningitis
* Participants must not have received prior neoadjuvant therapy for treatment of pancreatic neuroendocrine tumor. Use of somatostatin analogs prior to surgery is permitted
* Participants must not have received somatostatin analogs after surgery
* Participants must not be planning to receive warfarin while on protocol treatment. Other anticoagulants are allowed
* Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine
* Participants must not have known absorption issues that would limit the ability to absorb study agents
* Participants must not have had an arterial thromboembolic event, unstable angina, or myocardial infarction within 12 months prior to registration
* Participants must not have active or uncontrolled infection
* Participants must not have serious medical or psychiatric illness that could affect study participation in the judgement of the treating investigator
* Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen DRUG: Capecitabine, DRUG: Temozolomide
Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor, Stage I Pancreatic Neuroendocrine Tumor AJCC v8, Stage II Pancreatic Neuroendocrine Tumor AJCC v8, Stage III Pancreatic Neuroendocrine Tumor AJCC v8
Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA
Kyle Adams - Kyle.Adams@prismahealth.org
ALL
18 years and over
PHASE4
NCT06291727
Inclusion Criteria:
* Patient is at least 18 years of age who are scheduled for a primary elective TKA.
* Patient can ambulate at least 10 feet independently without human assistance.
* Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II
Exclusion Criteria:
* Patients scheduled for bilateral TKAs
* Contraindication to spinal anesthesia
* Revision TKAs
* Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)
* Workers' Compensation patient
* Type I Diabetes
* Type II Diabetes requiring insulin medication.
* Pre-operative narcotics use with the exception of tramadol.
* Renal insufficiency (GFR \< 60) that may impact post-operative protocol
* Cognitive deficiencies that prevent the patient from providing their own informed consent
* Language barrier preventing completion of study forms in English DRUG: Mepivacaine, DRUG: Bupivacaine
Anesthesia, Spinal, Arthroplasty, Replacement, Knee
knee arthroplasty, spinal anesthesia, same day discharge, mepivacaine, bupivacaine
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC (PEMDA-HN)
Flamingo Therapeutics - clinical@flamingotx.com
ALL
18 years and over
PHASE2
NCT05814666
Inclusion Criteria:
• Must have given written informed consent (signed and dated).
• Aged ≥18 years at the time of informed consent.
• Recurrent/metastatic histologically or cytologically proven squamous cell carcinoma of the head and neck that is considered incurable by local therapy. Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
• Presence of measurable tumor per RECIST v1.1 criteria.
• Detectable PD-L1 expression in tumor, defined as CPS ≥1 determined by a FDA or national regulatory agency of the country in which the patient resides.-approved test.
• Baseline fresh tumor biopsy or archival specimen.
• ECOG performance status of 0 or 1.
• Adequate organ function within 10 days of study treatment,
• Oxygen saturation on room air ≥92% by pulse oximetry.
• Females must be non-pregnant and non-lactating and either be postmenopausal or agree to adequate birth control.
• Males must be surgically sterile or agree to adequate birth control.
• Has an estimated life expectancy of at least 3 months.
• Has recovered from all complications or surgery and all toxicities of prior therapy
Exclusion Criteria:
• Prior therapy for metastatic HNSCC.
• Has disease suitable for local therapy with curative intent.
• Primary tumor of the nasopharynx.
• Has received prior therapy with an anti-programmed death 1 (PD-1), anti PD L1, or anti-programmed death-ligand-2 (PD-L2).
• Radiation therapy (or other non-systemic therapy) within 2 weeks of Day 1 of study treatment.
• Known autoimmune disease that has required systemic treatment
• Known immunodeficiency or receiving systemic steroid therapy that would be the equivalent of \>10 mg prednisone daily
• Prior allogeneic tissue/solid organ transplant.
• Has significant cardiovascular disease
• Has received a live vaccine within 30 days
• Active infection requiring systemic antiviral or antimicrobial therapy
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• History of other malignancies
• Active HIV infection except patients who are currently stable on antiretroviral therapy for at least 4 weeks
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Treated or untreated parenchymal brain metastases or leptomeningeal disease.
• Treatment with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent (if known), whichever is longer.
• Hypersensitivity to any component of danvatirsen or pembrolizumab.
DRUG: Danvatirsen, DRUG: Pembrolizumab
HNSCC
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC (PRESERVE-001)
Pan Zheng, MD, PhD - pzheng@oncoc4.com
ALL
18 years and over
PHASE1
NCT04140526
Inclusion Criteria:
• . Patients must have a histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
• In the Part A Phase I dose escalation study of ONC-392 monotherapy, patients with advanced/metastatic solid tumors of any histology are eligible for participation. Please note: tumor types of primary interest in this study are malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, colorectal cancer, any type of sarcoma.
• In Part B dose finding of the ONC-392 plus pembrolizumab combination, patients with advanced/metastatic solid tumors of any histology that Pembrolizumab has been approval as standard of care are eligible for participation.
• In Part C, patients with pancreatic cancer, triple negative breast cancer, non small cell lung cancer, melanoma, Head and Neck cancer, ovarian cancer, and other solid tumors are eligible.
• In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
• Patients must have RECIST V1.1 Measurable disease:
• Patient is male or female and \>18 years of age on day of signing informed consent.
• Patient must have a performance status of 0 or 1 on the ECOG Performance Scale
• Patient must have adequate organ function as indicated by the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1,500 /mcL; Plateletsa ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications; Renal: Serum creatinine ≤1.5 X upper limit of normal (ULN); Hepatic: Serum total bilirubin ≤1.5 X ULN; OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 ULN; AST (SGOT) and ALT (SGPT) ≤2.5 X ULN, OR ≤5 X ULN for patients with active liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN
• Patient has voluntarily agreed to participate by giving written informed consent.
• Female patient of childbearing potential has a negative urine or serum pregnancy test.
• Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.
Exclusion Criteria:
A patient meeting any of the following criteria is not eligible to participate in this study:
• Patients who have not recovered to CTCAE ≤ 1 from the AE due to cancer therapeutics. The washout period for cancer therapeutic drugs (such as chemotherapy, radioactive, or targeted therapy) is 21 days, and for antibody drug 28 days.
• Patients who are currently enrolled in a clinical trial of an investigational agent or device.
• Patients who are on chronic systemic steroid therapy at doses \>10 mg/day
• Patients who have active symptomatic brain metastasis or leptomeningeal metastasis.
• Patients who have an active infection requiring systemic IV therapy within 14 days of prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab.
• Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
• Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Patients who are pregnant or breastfeeding.
• For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab.
DRUG: ONC-392, DRUG: Pembrolizumab, DRUG: Docetaxel
Cervical Cancer, Gastric Cancer, Esophageal Cancer, Metastatic Breast Cancer, Non Small Cell Lung Cancer, Metastatic Prostate Cancer, Pancreas Cancer, Ovarian Cancer, Small Cell Lung Cancer, Salivary Gland Cancer, Urothelial Carcinoma, Advanced Solid Tumor, Gastroesophageal Junction Adenocarcinoma, Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Adenoid Cystic Carcinoma
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals with Moderate to Severe Opioid Use Disorder
Anthony Faso - anthony.faso@prismahealth.org
ALL
18 years to 65 years old
PHASE2
NCT06384157
Inclusion Criteria:
* Participants are eligible to be included in the study only if all of the following criteria apply:
• Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed consent.
• Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
• Males or females with moderate or severe OUD by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, who are looking to transition from daily short-term opioid agonist treatment (medically supervised withdrawal) to non-opioid treatment.
• Have not been on medication for opioid use for 3 months prior to the current treatment episode, and satisfies either a or b below.
• The participant will initiate, or is undergoing medically supervised withdrawal, and: * In the opinion of the investigator, the participant is able to achieve a stable dose of TM buprenorphine between ≤24 mg inclusive prior to randomization * Current opioid agonist treatment does not exceed 35 days from the start of TM buprenorphine to the end of taper on study (Study Day 7)
• The participant recently completed medically supervised withdrawal outside of the study, and: * Time elapsed between last dose of TM buprenorphine and Study Day 1/randomization does not exceed 10 calendar days * Recently completed opioid agonist treatment does not exceed 35 days of TM buprenorphine dosing days (inclusive of medically assisted withdrawal dosing and the study taper week \[Study Day 7\])
• Male participants who are sexually active with individuals who are of childbearing potential must agree to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication.
• Female participant of non-childbearing potential; or a female of childbearing potential if she agrees to use a medically acceptable form of contraception from Screening until at least 90 days after the last dose of study medication, she is not pregnant as confirmed by a negative serum screening and or urine human chorionic gonadotrophin test on Study Day 1, and she is not lactating.
• Body mass index (BMI) within 18.0 to 40.0 kg/m2 (inclusive).
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply:
• Have a current diagnosis, other than OUD, requiring chronic opioid treatment.
• Have a concurrent primary substance use disorder, as defined by DSM 5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
• Meet DSM 5 criteria for severe substance use disorder other than opioids.
• Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder that would impact participation in the study as judged by an Investigator or medically responsible physician.
• Had an opioid overdose event within the 6 months prior to the Screening Visit.
• Uses any substance of abuse via the injection route more than 1 time per week.
• Have clinically significant abnormal biochemistry, hematology or urinalysis results that would impact participation in the study as judged by an Investigator or medically responsible physician.
• Have a history of narcolepsy, cataplexy, obstructive or central sleep apnea.
• Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
• History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
• Serious cardiac illness or other cardiac assessments including, but not limited to:
• Uncontrolled arrhythmias
• History of congestive heart failure
• Myocardial infarction \<6 months from receipt of first dose of investigational medicinal product (IMP)
• Uncontrolled symptomatic angina
• QT interval corrected with Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females or history of prolonged QT syndrome
• Have any combination of the following at screening:
• Total bilirubin ≥1.5×upper limit of normal (ULN) (with direct bilirubin \>1.3 mg/dL)
• Alanine aminotransferase (ALT) ≥3×ULN
• Aspartate aminotransferase (AST) ≥3×ULN
• International normalized ratio (INR) \>1.2×ULN
• Estimated glomerular filtration rate \<60 mL/min by Cockroft-Gault formula
• Current symptomatic hepatic or biliary disease, including participants with cholecystectomy \<90 days prior to Screening.
• Use of a long-acting buprenorphine or naltrexone treatment for OUD within 2 years or 1 year of the screening visit, respectively.
• Concurrent treatment or treatment with an investigational drug, or participation in any other clinical study within 30 days prior to signing the informed consent form.
• Blood or platelets donation of greater than 500 mL within 56 days or plasma donation within 7 days of screening; clinically significant anemia or low hemoglobin (\<11 g/dL for females, \<12 g/dL for males).
• Known allergy or hypersensitivity to IMP or its excipients.
• Any condition that, in the opinion of an Investigator or medically responsible physician, would interfere with evaluation of the IMP or interpretation of participant safety or study results.
• Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (i.e., site staff, Indivior, or Clinical Research Organization \[CRO\] employee).
• Participants who are unable, in the opinion of an Investigator or medically responsible physician, to comply fully with the study requirements.
• Current incarceration, treatment for OUD required by court order, or pending incarceration/legal action that could prevent participation or compliance in the study.
DRUG: INDV-2000, OTHER: Placebo
Opioid Use Disorder
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-Small Cell Lung Cancer, ALCHEMIST Trial
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
18 years and over
PHASE3
NCT04267848
Inclusion Criteria:
* A female of childbearing potential is a sexually mature female who:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Previously registered to A151216
* Central and/or local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
* Central and/or local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
* Central and/or local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
* Note: Central testing of EGFR was discontinued as of A081801 Update 10; central testing of ALK and PD-L1 will continue. Local testing results by a local CLIA certified laboratory is required for EGFR and acceptable for ALK. The report must indicate the result as well as the CLIA number of the laboratory that performed the assay. Local result of PD-L1 by DAKO 22C3, Dako 28-8, EIL3N or SP263 are acceptable for enrollment on A081801. Patients with local results for EGFR, ALK and PD-L1 still need to be registered to A151216 and follow all the submissions requirements but do NOT need to wait for the results to proceed to A081801 registration.
* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017
* Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
* No prior allogeneic tissue/solid organ transplant
* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
* 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 done =\< 7 days prior to registration is required
* No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
* No hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
* No known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8 gm/dl
* Calculated (Calc.) creatinine clearance \>= 45 mL/min
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cisplatin, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography, DRUG: Gemcitabine Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, OTHER: Observation, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, DRUG: Pemetrexed Disodium, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Squamous Carcinoma, Lung Non-Squamous Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
IRB@prismahealth.org
ALL
12 months to 21 years old
PHASE2
NCT03155620
Inclusion Criteria:
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis \[LCH\], juvenile xanthogranuloma \[JXG\], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma are not eligible
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
* Please note: Samples that have been decalcified using standardly utilized acid-based decalcification methods are not generally suitable for MATCH study testing; the nucleic acids will have been degraded in the decalcification process
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor molecular profiling report availability requirement for Stage 2 of Pediatric MATCH (patients enrolled starting 2022): In stage 2 of the study, no tumor samples will be submitted for centralized clinical tumor profiling; instead, a tumor molecular profiling report from a College of American Pathologists (CAP)/ Clinical Laboratory Improvements Amendments (CLIA)-approved testing laboratory must be submitted for review by the Molecular Review Committee (MRC)
* This molecular profiling must have been performed on a tumor sample that was obtained at any point after initial tumor recurrence/progression and must be accompanied by a pathology report for the same tumor specimen; a molecular profiling report for a diagnostic (pre-treatment) tumor sample will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus. In the event that molecular profiling reports are available from multiple timepoints, the most recent report should be prioritized for study submission
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age); note: neurologic deficits in patients with central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must have radiographically measurable disease; measurable disease based on imaging obtained less than or equal to 56 days prior to enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
* Note: The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans) except as noted for neuroblastoma
* Elevated tumor markers in plasma or CSF
* Previously radiated lesions that have not demonstrated clear progression post radiation
* Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: NOTE: patient does not need to meet all subprotocol criteria at time of enrollment onto the APEC1621SC screening protocol, but will need to meet all criteria prior to enrollment on any assigned treatment subprotocol. Patients must be enrolled onto a subprotocol within 2 weeks (14 days) of treatment assignment
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age); Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of treatment with subprotocol specified therapy, the patients must have radiographically measurable disease; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard MRI or CT
* Note: The following do not qualify as measurable disease:
* Malignant fluid collections (e.g., ascites, pleural effusions)
* Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
* Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography \[PET\] scans) except as noted for neuroblastoma
* Elevated tumor markers in plasma or CSF
* Previously radiated lesions that have not demonstrated clear progression post radiation
* Leptomeningeal lesions that do not meet the measurement requirements for RECIST 1.1
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: At the time of enrollment onto a subprotocol, the following general criteria for initiation of therapy will be required:
* Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer directed therapy prior to enrollment to the subprotocol; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
* Cytotoxic chemotherapy or other anticancer agents known to be myelosuppressive: for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment \>= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
* Anticancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts \[ANC\]): \>= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
* 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
* Corticosteroids: If used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid
* Hematopoietic growth factors: \>= 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
* Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
* Stem cell infusions (with or without total-body irradiation \[TBI\]):
* Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \>= 84 days after infusion and no evidence of graft versus host disease (GVHD)
* Autologous stem cell infusion including boost infusion: \>= 42 days
* Cellular therapy: \>= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer (NK) cells, dendritic cells, etc.)
* X-ray therapy (XRT)/External Beam Irradiation including Protons: \>= 14 days after local XRT; \>= 150 days after TBI, craniospinal XRT or if radiation to \>= 50% of the pelvis; \>= 42 days if other substantial bone marrow (BM) radiation; note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): \>= 42 days after systemically administered radiopharmaceutical therapy
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:
* Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: 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:
* Age: 1 to \< 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
* Age: 2 to \< 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
* Age: 6 to \< 10 years; maximum serum creatinine (mg/dL): male 1; female 1
* Age: 10 to \< 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
* Age: 13 to \< 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
* Age: \>= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Serum glutamate pyruvate transaminase (SGPT) (alanine transferase \[ALT\]) =\< 135 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Patients must be able to swallow intact capsules/tablets, unless otherwise specified in the subprotocol to which they are assigned
* GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: Agent specific limitations on prior therapy will be included with specific treatment subprotocols
Exclusion Criteria:
* GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, or because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in females who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Concomitant medications
* Corticosteroids: at the time of consent and enrollment to regimen specific subprotocols, patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment to the subprotocol will not be eligible; if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid
* Investigational drugs: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
* Anticancer agents: patients must meet criteria for prior therapy at the time of consent and enrollment to a subprotocol; other investigational agents may not be administered to patients while they are receiving study drug as part of a subprotocol
* Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible
* GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have an uncontrolled infection are not eligible
* GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Patients who have had a prior solid organ transplant are not eligible
* GENERAL EXCLUSION CRITERIA FOR SUBPROTOCOLS: Additional agent specific criteria will be included with specific treatment subprotocols PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration and Biopsy, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, DRUG: Ensartinib, DRUG: Erdafitinib, OTHER: Laboratory Biomarker Analysis, DRUG: Larotrectinib Sulfate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Mutation Carrier Screening, DRUG: Olaparib, DRUG: Palbociclib, OTHER: Pharmacological Study, PROCEDURE: Positron Emission Tomography, PROCEDURE: Radionuclide Imaging, DRUG: Samotolisib, DRUG: Selpercatinib, DRUG: Selumetinib Sulfate, DRUG: Tazemetostat, DRUG: Tipifarnib, DRUG: Ulixertinib, DRUG: Vemurafenib, PROCEDURE: X-Ray Imaging
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Histiocytic Sarcoma, Juvenile Xanthogranuloma, Langerhans Cell Histiocytosis, Malignant Glioma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Soft Tissue Sarcoma, Refractory Ewing Sarcoma, Refractory Glioma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Rhabdoid Tumor, Stage III Osteosarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Osteosarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7, Wilms Tumor
The Arteriovenous Vascular (AV) ACCESS Trial
Christopher Carsten, MD - Chris.Carsten@prismahealth.org
ALL
60 years and over
NA
NCT04646226
Inclusion Criteria:
* Age 60 years or older
* End-stage kidney disease on hemodialysis via a central venous catheter
* Hemodialysis is the long-term modality of treatment for end-stage kidney disease
* Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
* Referred by patient's nephrologist for placement of arteriovenous access
* At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
* Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
* Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
* Patient agreed to study participation and signed the informed consent
Exclusion Criteria:
* Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
* Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
* Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
* Anticipated kidney transplant within 12 months
* Anticipated conversion to peritoneal dialysis within 12 months
* Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
* Anticipated non-compliance with medical care based on physician judgment
* A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation. DEVICE: AV graft, PROCEDURE: surgical intervention for creation of a fistula
End-Stage Kidney Disease, Hemodialysis Complication
Hemodialysis, End-Stage Kidney Disease, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Medical Director - ClinicalTrials@arcusbio.com
ALL
18 years and over
PHASE2
NCT05329766
Key
Inclusion Criteria:
* Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
* Eastern cooperative oncology group (ECOG) Performance Score of 0-1
* At least one measurable target lesion per RECIST v1.1.
* Adequate organ and marrow function
* Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing
Key Exclusion Criteria:
* Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
* Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
* Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
* Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
* History of trauma or major surgery within 28 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply. DRUG: Domvanalimab, DRUG: Quemliclustat, DRUG: Zimberelimab, DRUG: Fluorouracil, DRUG: Leucovorin, DRUG: Oxaliplatin
Gastrointestinal Tract Malignancies
Domvanalimab, Quemliclustat, Zimberelimab, Esophageal adenocarcinoma, Gastric adenocarcinoma, Gastric cancer, Gastroesophageal junction cancer, Anti-PD-1 antibody, Anti-CD73, anti-TIGIT antibody
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
Immunocore Medical Information - medical.information@immunocore.com
ALL
18 years and over
PHASE1
NCT04262466
Inclusion Criteria:
• ECOG PS 0 or 1
• HLA-A\*02:01 positive
• PRAME positive tumor
• Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
• If applicable, must agree to use highly effective contraception
Exclusion Criteria:
• Symptomatic or untreated central nervous system metastasis
• Recent bowel obstruction
• Ongoing ascites or effusion requiring recent drainages
• Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
• Inadequate washout from prior anticancer therapy
• Significant ongoing toxicity from prior anticancer treatment
• Out-of-range laboratory values
• Clinically significant lung, heart, or autoimmune disease
• Ongoing requirement for immunosuppressive treatment
• Prior solid organ or bone marrow transplant
• Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
• Significant secondary malignancy
• Hypersensitivity to study drug or excipients
• Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
• Pregnant or lactating
• Any other contraindication for applicable combination partner based on local prescribing information
DRUG: Brenetafusp, DRUG: Brenetafusp and pembrolizumab, DRUG: Brenetafusp and chemotherapy, DRUG: Brenetafusp and monoclonal antibodies and chemotherapy, DRUG: Brenetafusp and tebentafusp, DRUG: Brenetafusp and bevacizumab, DRUG: Brenetafusp and kinase inhibitors
Select Advanced Solid Tumors
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
IRB@prismahealth.org
ALL
Up to 50 years old
PHASE3
NCT05235165
Inclusion Criteria:
* Patients must be \< 50 years at the time of enrollment.
* Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
* Note: Patient must have eligibility confirmed by rapid central imaging review.
* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
* Patients must have a histological diagnosis of osteosarcoma.
* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion Criteria:
* Patients with unresectable primary tumor.
* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
* Patients with evidence of extrapulmonary metastatic disease.
* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
* 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. PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, OTHER: Questionnaire Administration, PROCEDURE: Thoracoscopy, PROCEDURE: Thoracotomy
Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
Study of Kidney Tumors in Younger Patients
Site Public Contact - kim.williams3@prismahealth.org
ALL
Up to 29 years old
NCT00898365
Inclusion Criteria:
* Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study
* Eligible tumors include (but are not limited to):
* Nephroblastic tumors
* Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia \[diffuse, focal\])
* Nephrogenic rests and nephroblastomatosis
* Cystic nephroma and cystic partially differentiated nephroblastoma
* Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
* Mesoblastic nephroma (cellular, classic, mixed)
* Clear cell sarcoma
* Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system \[CNS\])
* Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
* Angiolipoma
* Ossifying renal tumor of infancy
* Patients with the first occurrence of the following tumors are also eligible:
* Extrarenal nephroblastoma or extrarenal neprogenic rests
* Malignant rhabdoid tumor occurring anywhere outside the central nervous system
* Required specimens, reports, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures
* For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy\*\*\*), the following submissions are required:
* A complete set of recut hematoxylin and eosin (H \& E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy)
* \* Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor \[FHWT\] patients discovered to have diffuse anaplastic Wilms tumor \[DAWT\] at delayed nephrectomy and plan to enroll at delayed nephrectomy)
* Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.
* Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
* Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
* Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
* Copies of images and institutional report of chest CT for all malignant tumors
* Institutional surgical report(s) and Pre-Treatment Surgical Checklist
* CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)
* Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only - these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. However, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
* Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
* 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 OTHER: Cytology Specimen Collection Procedure, OTHER: Laboratory Biomarker Analysis
Rhabdoid Tumor of the Kidney, Clear Cell Sarcoma of the Kidney, Adult Cystic Nephroma, Anaplastic Kidney Wilms Tumor, Angiolipoma, Cellular Congenital Mesoblastic Nephroma, Classic Congenital Mesoblastic Nephroma, Congenital Mesoblastic Nephroma, Cystic Partially Differentiated Kidney Nephroblastoma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Extrarenal Rhabdoid Tumor, Kidney Medullary Carcinoma, Ossifying Renal Tumor of Infancy, Papillary Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Kidney Neoplasm, Kidney Oncocytoma, Kidney Wilms Tumor, Metanephric Adenofibroma, Metanephric Adenoma, Metanephric Stromal Tumor, Metanephric Tumor, Mixed Congenital Mesoblastic Nephroma, Renal Cell Carcinoma, Wilms Tumor
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)
Addie Hunnicutt Hunnicutt - ahunnicutt@ghs.org
ALL
NCT04174157
Inclusion Criteria:
* Patients treated with OAV-101 with a genetically confirmed diagnosis of SMA regardless of the date of diagnosis.
* Appropriate consent/assent has been obtained for participation in the registry
Exclusion Criteria:
• Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA. Note: Patients who are participating in a Compassionate Use Program (CUP) for OAV-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of a genetic or clinical diagnosis of SMA.
OTHER: Prospective observational registry, DRUG: Zolgensma
Spinal Muscular Atrophy (SMA)
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
IRB@prismahealth.org
ALL
2 years to 21 years old
PHASE3
NCT03871257
Inclusion Criteria:
* Patients must be \>= 2 years and =\< 21 years at the time of enrollment
* Patients must have a body surface area (BSA) of \>= 0.5 m\^2 at enrollment
* Patients must have neurofibromatosis type 1 (NF1) based on clinical criteria and/or germline genetic testing
* Patients must be newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
* For patients with optic pathway gliomas (OPGs):
* Newly-diagnosed patients with OPG are eligible if there are neurologic symptoms (including visual dysfunction, as defined below) or other exam findings associated with the tumor
* Previously-diagnosed patients with OPG are eligible if they have new or worsening neurologic symptoms (including visual dysfunction, as defined below) or have tumor growth
* For both newly-diagnosed and previously-diagnosed OPG, the patient may be eligible, irrespective of whether there has been tumor growth or other neurological symptoms or worsening, if they meet at least one of the following visual criteria:
* Visual worsening, defined as worsening of visual acuity (VA) or visual fields (VF) documented within the past year (by examination or history); OR
* Significant visual dysfunction (defined as VA worse than normal for age by 0.6 logMAR \[20/80, 6/24, or 2.5/10\] or more in one or both eyes)
* For patients with LGG in other locations (i.e., not OPGs):
* Newly-diagnosed patients with LGG are eligible if there are neurologic symptoms or other exam findings associated with the tumor
* NOTE: Newly-diagnosed patients with LGG without associated neurologic symptoms or exam findings are not eligible
* Previously-diagnosed patients with LGG are eligible if they have new or worsening neurologic symptoms or have tumor growth
* Although not required, if a biopsy/tumor resection is performed, eligible histologies will include all tumors considered LGG or low-grade astrocytoma (World Health Organization \[WHO\] grade I and II) by 5th edition WHO classification of central nervous system (CNS) tumors with the exception of subependymal giant cell astrocytoma
* Patients must have two-dimensional measurable tumor \>= 1 cm\^2
* Patients with metastatic disease or multiple independent primary LGGs are allowed on study
* Creatinine clearance or radioisotope glomerular filtration Rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender (within 7 days prior to enrollment) as follows:
* Age; maximum serum creatinine (mg/dL)
* 2 to \< 6 years; 0.8 (male) and 0.8 (female)
* 6 to \< 10 years; 1 (male) and 1 (female)
* 10 to \< 13 years; 1.2 (male) and 1.2 (female)
* 13 to \< 16 years; 1.5 (male) and 1.4 (female)
* \>= 16 years; 1.7 (male) and 1.4 (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 glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x upper limit of normal (ULN) = 135 U/L (within 7 days prior to enrollment). For the purpose of this study, the ULN for SGPT is 45 U/L
* Albumin \>= 2 g/dL (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 (QTc) interval =\< 450 msec by electrocardiography (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 have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
* 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. Patients \>= 18 years of age must have a blood pressure =\< 130/80 mmHg at the time of enrollment (with or without the use of antihypertensive medications).
* Note: 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
* For patients who undergo a surgery on the target tumor (not required), a pre- and post-operative\* MRI of the brain (with orbital cuts for optic pathway tumors) or spine (depending on the site(s) of primary disease) with and without contrast must also be performed within 4 weeks prior to enrollment
* The post-operative MRIs should be performed ideally within 48 hours after surgery if possible
* 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
* Patients must have receptive and expressive language skills in English or Spanish to complete the quality of life (QOL) and neurocognitive assessments
* 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:
* Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant. Prior surgical intervention is permitted
* Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible
* Patients may not be receiving any other investigational agents
* Patients with any serious medical or psychiatric illness/ condition, including substance use disorders likely in the judgement of the investigator to interfere or limit compliance with study requirements/treatment are not eligible
* Patients who, in the opinion of the investigator, are not able to comply with the study procedures 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 are not eligible
* 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
* Cardiac conditions:
* 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
* 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 ULN adjusted by age are not eligible
* Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor, or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN), such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study
* Treatments and/or medications patient is receiving that would make her/him ineligible, such as:
* Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E
* Surgery within 2 weeks prior to enrollment, with the exception of surgical placement for vascular access or cerebrospinal fluid (CSF) diverting procedures such as endoscopic third ventriculostomy (ETV) and ventriculo-peritoneal (VP) shunt.
* Note: Patients must have healed from any prior surgery prior to enrollment
* Patients who have an uncontrolled infection are not eligible DRUG: Carboplatin, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Selumetinib Sulfate, DRUG: Vincristine Sulfate
Low Grade Glioma, Neurofibromatosis Type 1, Visual Pathway Glioma
Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors
Site Public Contact - kim.williams3@prismahealth.org
ALL
18 years and over
PHASE3
NCT03996265
Inclusion Criteria:
* Be at least 18 years of age
* Be diagnosed with cancer
* Have stable disease or no evidence of disease
* Report WORST level of fatigue in the past week as moderate to severe (i.e., a score \>= 4 on a 0-10 scale, screening measures, question 1)
* Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) 2 or more months prior to enrollment. Participants currently receiving oral maintenance, targeted, or hormonal therapy are eligible. Participants receiving intravenous supportive therapy (e.g., bisphosphonates) are eligible
* Able to read and speak English
* Currently not pregnant or breastfeeding. Women of child-bearing potential must agree to use adequate contraception, i.e., abstinence, IUD (intrauterine device), hormonal contraceptive (birth control pills) or barrier method (condoms) prior to study entry and for the duration of study participation
* Be capable of providing written informed consent
Exclusion Criteria:
* Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban
* Be taking a monoamine oxidase inhibitor (MAOI), linezolid, or methylene blue within 2 weeks prior to enrollment
* Be taking any anti-psychotic medications within a week prior to enrollment
* Have a history of renal impairment (i.e., glomerular filtration rate \< 45)
* Have a history of cirrhosis (i.e., Child-Pugh score \>= 5)
* Have a history of seizures
* Have a history of bulimia or anorexia nervosa
* Report a history of sensitivity to bupropion
* Report an allergy to lactose
* Have a psychiatric or neurological disorder that would interfere with study participation per physician or physician's designee DRUG: Bupropion Hydrochloride Controlled-release, OTHER: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Be Diagnosed With Cancer and Have Completed Systemic Therapy
Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
Ki Chung, MD - ki.chung@prismahealth.org
ALL
18 years to 80 years old
PHASE1
NCT05766748
Inclusion Criteria:
• Patient must have histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas for which potential curative measures, such as resection of an isolated metastasis, are not available.
• Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen.
• Toxicity from prior chemotherapy other than alopecia has recovered to Grade ≤ 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy).
• Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age.
• Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (75 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
• Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: * AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 x ULN is acceptable. Total bilirubin ≤ 1.5 × ULN. * Estimated creatinine clearance of \> 60 mL/min (per Cockroft-Gault formula)
• Patient has ECOG performance status of ≤ 2
• Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities.
Exclusion Criteria:
• Patient has a life expectancy, per investigator assessment, of less than 3 months.
• Patient has experienced an increase of ECOG to \> 2 between Screening and the time of first dose with study drug.
• Patient has active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.
• Patients receiving CYP 2C8 inhibitors noted in Section 5.3 of the protocol.
• Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
• Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
• Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
• Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of study drug.
• Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 14 days of starting study drug. Patients who are participating in non-interventional clinical trials (e.g., quality of life, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
DRUG: Azeliragon
Metastatic Pancreatic Cancer
azeliragon
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Site Public Contact - Kim.Williams3@prismahealth.org
ALL
18 years to 75 years old
PHASE3
NCT04530565
Inclusion Criteria:
* ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
* Patient must be \>= 18 and =\< 75 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
* Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)
* Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation
* NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
* Patient must not have a diagnosis of BCR/ABL T-ALL
* Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
* Patient must not have unstable epilepsy that requires treatment
* Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
* ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
* Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center
* 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 registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, 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)
* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment
* Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X the institutional upper limit of normal (ULN) (obtained =\< 28 days prior to step 1 registration)
* Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation) (obtained =\< 28 days prior to step 1 registration)
* Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met
* Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy
* 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 or on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
* Patients with a prior 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 not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible
* Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
* 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 must be class 2B or better
* Investigators must confirm which TKI patient is to receive
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only
* ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2
* Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted)
* NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization
* Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional upper limit of normal (ULN)
* AST(SGOT)/ ALT(SGPT) =\< 2 X the institutional upper limit of normal (ULN)
* Estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation)
* Investigators must confirm which TKI patient is to receive.
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization
* Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated
* Patients must have resolved any serious infectious complications related to therapy
* Any significant medical complications related to therapy must have resolved
* ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION)
* Institution has received centralized MRD results confirming positive status
* Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =\< 2 X institutional ULN
* Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =\< 2 X institutional upper limit of normal (ULN)
* Patients who presented with acute organ dysfunction must have an estimated creatinine clearance \> 45 mL/min (based on Cockcroft-Gault equation)
* Investigators must confirm which TKI patient is to receive
* NOTE: Patients with known T315I mutation status should receive ponatinib treatment
* For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined
* Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy
* Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration and Biopsy, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Echocardiography, PROCEDURE: Electrocardiography, PROCEDURE: Lumbar Puncture, DRUG: Mesna, DRUG: Methotrexate, PROCEDURE: Multigated Acquisition Scan, DRUG: Ponatinib Hydrochloride, DRUG: Prednisone, DRUG: Vincristine Sulfate
B Acute Lymphoblastic Leukemia With t(9,22)(q34.1,q11.2), BCR-ABL1
Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)
Medical Information - medicalinfo@vrtx.com
ALL
Up to 6 month(s) old
NCT06506773
Key
Inclusion Criteria:
* Participants with CF less than (\<) 6 months of age at the index date
* Participants not eligible to receive commercial Kalydeco™ (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator
Key Exclusion Criteria:
* Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator
Other protocol defined Inclusion/Exclusion criteria apply. Cystic Fibrosis
De-Implementing Fall Prevention Alarms in Hospitals
Whitney Smith - whitney.smith@prismahealth.org
ALL
18 years and over
NA
NCT06089239
Inclusion Criteria:
* Stakeholders in fall prevention at up to 30 participating NDNQI hospitals
Exclusion Criteria:
- OTHER: High Intensity Coaching, OTHER: Low Intensity Coaching
Accidental Fall, Patient Safety, Hospital Acquired Condition, Clinical Alarms, Mentoring
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)
Debiopharm International S.A - clinicaltrials@debiopharm.com
ALL
5 years to 8 years old
PHASE3
NCT06129539
Inclusion Criteria:
• Diagnosis of central precocious puberty and currently receiving GnRHa therapy.
• Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
• Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged 2 to 4 years inclusive (i.e., \<5 years) and/or 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
• Participant to receive at least 1 year of GnRHa therapy from study treatment start.
• Start of initial GnRHa therapy no later than 18 months after onset of the first signs of Central precocious puberty (CPP).
• Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy.
• Pubertal-type LH response following a GnRH/GnRHa stimulation test, or random non-stimulated serum (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy.
• Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys, prior to the initiation of GnRHa therapy.
Exclusion Criteria:
• Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
• Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy.
• Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
• Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
• Other than GnRHa therapy, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth.
• Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
• Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
• Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
• Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
• Use of anticoagulants (heparin or coumarin derivatives).
DRUG: Debio 4326
Central Precocious Puberty
Methocarbamol in Ventral and Inguinal HR
Jeremy A Warren, MD - jeremy.warren@prismahealth.org
ALL
18 years and over
PHASE4
NCT05388929
Inclusion Criteria:
* \>18 y/o
* Patients undergoing open primary ventral hernia repair (group 1)
* Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2)
* Patients undergoing open incisional hernia repair (group 3)
* Robotic repair ventral or incisional hernias (group 4)
* Given consent for randomization
Exclusion Criteria:
* \<18 y/o
* Pregnancy
* Chronic opioid users DRUG: Methocarbamol, DRUG: Standard Opioid, DRUG: Standard opioid plus methocarbamol
Ventral Hernia, Inguinal Hernia
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Angie Schinkel - clinicaltrials@poseida.com
ALL
18 years and over
PHASE1
NCT06014762
Inclusion Criteria
• Must have signed written, informed consent.
• Males or females ≥ 18 years of age.
• Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL,and tFL or follicular lymphoma Grade 3B.
• Diagnosis of the disease based on WHO 2016 (Swerdlow, 2016) criteria.
• Subjects must have measurable disease as defined by Lugano 2016 criteria (Cheson, 2016).
• Must have relapsed/refractory disease and have received adequate prior anti-cancer therapy, as defined below: a. Prior systemic chemotherapy must include a line of chemoimmunotherapy that includes an anti-CD20 antibody, an anthracycline, and 1 or more of the following: i. No response to first-line therapy (primary refractory disease). Refractory disease (defined as SD, PD, PR or CR with relapse before 3 months). ii. Progressive disease following two or more lines of therapy. However, SD as the best response after at least 2 cycles of the last line of therapy with SD duration no longer than 6 months from the last dose of therapy is also acceptable. iii. Refractory post-autologous stem cell transplant (ASCT). Disease progression or relapse occurring at less than or equal to 12 months of undergoing ASCT (must have biopsy proven recurrence in relapsed patients). If salvage therapy is given post-ASCT, the patient must have had no response to or relapsed after the last line of therapy. iv. Refractory disease (SD, PD, PR or CR with relapse before 3 months) or relapsed disease (defined as CR/PR with relapse on, or after lasting at least 3 months but no more than 12 months), to CD20 antibody and anthracycline containing first-line therapy.
• Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-CD19CD20-ALLO1 administration (both males and females of childbearing potential).
• Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion chemotherapy regimen (females of childbearing potential).
• Must be at least 90 days since ASCT, if performed.
• Treatment with prior CD19 targeted therapy is allowed, provided the last dose was administered at least 90 days before the start of P-CD19CD20-ALLO1 treatment in this study. Must be at least 3 months since autologous CAR-T therapy if such therapy was administered (medical monitor must approve prior CAR-T therapy or other prior T cell targeted therapy).
• Must have adequate vital organ function, defined as follows (or medical monitor approval):
• Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault formula and not dialysis-dependent.
• Adequate hematologic function, including: i. Absolute neutrophil count (ANC) ≥ 1000/μL in the absence of growth factor support (granulocyte colony stimulating factor \[G-CSF\] within 7 days or peg-G-CSF within 14 days) ii. Platelet count ≥ 50,000/μL in the absence of transfusion support (platelet transfusion within 7 days) iii. Hemoglobin ≥ 8 g/dL in the absence of transfusion support (red blood cell count or whole blood within 7 days) c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN), and total bilirubin ≤ 2.0 mg/dL (unless there is a history of Gilbert's Syndrome in which case bilirubin levels ≤ 3 mg/dL). d. Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 4 weeks of enrollment.
• Must have recovered from toxicities due to prior therapies to Grade ≤ 2 according to the NCI CTCAE v5.0 criteria or to the subject's prior baseline.
• Must have an ECOG performance status of 0 to 1. Exclusion Criteria
• Is pregnant or lactating.
• Has inadequate venous access.
• Has active hemolytic anemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), disseminated intravascular coagulation, leukostasis, or amyloidosis.
• Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies including basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, breast, or Bowen's disease. Patients with other curatively treated malignancies with low risk of recurrence not listed may also be considered eligible after review and approval by the Sponsor medical monitor.
• Has active autoimmune disease, such as psoriasis, multiple sclerosis, lupus, rheumatoid arthritis, etc. (the medical monitor will determine if a disease is active and autoimmune).
• Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, primary CNS lymphoma, etc. (the medical monitor will determine if significant).
• Has an active systemic infection (e.g., causing fevers or requiring antimicrobial treatment).
• Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by hepatitis C polymerase chain reaction (PCR) on multiple occasions and with medical monitor approval.
• Is positive for human herpes virus (HHV)-6 or HHV-7 infection by PCR at the Screening Visit (subjects may be included in the study if they are HHV-6 or HHV-7 IgG antibody-positive but PCR-negative).
• Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia (e.g., atrial fibrillation, sustained \[\> 30 seconds\] ventricular tachyarrhythmias, etc.).
• Has any psychiatric or medical disorder (e.g., cardiovascular, endocrine, renal, gastrointestinal, genitourinary, immunodeficiency or pulmonary disorder not otherwise specified) that would, in the opinion of the Investigator or medical monitor, preclude safe participation in and/or adherence to the protocol (including medical conditions or laboratory findings that indicate a significant probability of not qualifying for or being unable to undergo, LD chemotherapy and/or CAR-T cell administration).
• Has received non-mAb anti-cancer medications within 2 weeks of the time of initiating LD chemotherapy.
• Has received mAb therapy within 4 weeks of initiating LD chemotherapy.
• Has received immunosuppressive medications within 2 weeks of the time of administration of P-CD19CD20-ALLO1, and/or expected to require them while on study (the medical monitor will determine if a medication is considered immunosuppressive.)
• Has received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) of the administration of P-CD19CD20-ALLO1 or is expected to require it during the course of the study. (Topical and inhaled steroids are permitted. Systemic corticosteroids are contraindicated after receiving P-CD19CD20-ALLO1 cells outside of study-specific guidance or medical monitor approval).
• Has CNS metastases or CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions, cauda equina syndrome, and spinal cord compression).
• Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Has a history of having undergone allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. Subjects with prior history of allogeneic stem cell transplant may be enrolled if they are not on immunosuppressive medications and with medical monitor approval.
• Has received prior allogeneic genetically modified cellular therapy or was treated with experimental allogeneic cell therapy.
• History or Grade ≥ 3 HLH/MAS or neurotoxicity with prior therapies (all symptoms of HLH/MAS, neurotoxicity, or CRS from prior therapies must be resolved at the time of enrollment).
• Has positive DAT at Screening Visit (may be allowed with medical monitor approval).
• Must have signed written, informed consent.
• Males or females ≥ 18 years of age.
• Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL,and tFL or follicular lymphoma Grade 3B.
• Diagnosis of the disease based on WHO 2016 (Swerdlow, 2016) criteria.
• Subjects must have measurable disease as defined by Lugano 2016 criteria (Cheson, 2016).
• Must have relapsed/refractory disease and have received adequate prior anti-cancer therapy, as defined below: a. Prior systemic chemotherapy must include a line of chemoimmunotherapy that includes an anti-CD20 antibody, an anthracycline, and 1 or more of the following: i. No response to first-line therapy (primary refractory disease). Refractory disease (defined as SD, PD, PR or CR with relapse before 3 months). ii. Progressive disease following two or more lines of therapy. However, SD as the best response after at least 2 cycles of the last line of therapy with SD duration no longer than 6 months from the last dose of therapy is also acceptable. iii. Refractory post-autologous stem cell transplant (ASCT). Disease progression or relapse occurring at less than or equal to 12 months of undergoing ASCT (must have biopsy proven recurrence in relapsed patients). If salvage therapy is given post-ASCT, the patient must have had no response to or relapsed after the last line of therapy. iv. Refractory disease (SD, PD, PR or CR with relapse before 3 months) or relapsed disease (defined as CR/PR with relapse on, or after lasting at least 3 months but no more than 12 months), to CD20 antibody and anthracycline containing first-line therapy.
• Must be willing to practice birth control from the time of Screening and throughout the first year of the study after P-CD19CD20-ALLO1 administration (both males and females of childbearing potential).
• Must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 3 days prior to initiating the lymphodepletion chemotherapy regimen (females of childbearing potential).
• Must be at least 90 days since ASCT, if performed.
• Treatment with prior CD19 targeted therapy is allowed, provided the last dose was administered at least 90 days before the start of P-CD19CD20-ALLO1 treatment in this study. Must be at least 3 months since autologous CAR-T therapy if such therapy was administered (medical monitor must approve prior CAR-T therapy or other prior T cell targeted therapy).
• Must have adequate vital organ function, defined as follows (or medical monitor approval):
• Serum creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft-Gault formula and not dialysis-dependent.
• Adequate hematologic function, including: i. Absolute neutrophil count (ANC) ≥ 1000/μL in the absence of growth factor support (granulocyte colony stimulating factor \[G-CSF\] within 7 days or peg-G-CSF within 14 days) ii. Platelet count ≥ 50,000/μL in the absence of transfusion support (platelet transfusion within 7 days) iii. Hemoglobin ≥ 8 g/dL in the absence of transfusion support (red blood cell count or whole blood within 7 days) c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN), and total bilirubin ≤ 2.0 mg/dL (unless there is a history of Gilbert's Syndrome in which case bilirubin levels ≤ 3 mg/dL). d. Left ventricular ejection fraction (LVEF) ≥ 45%. LVEF assessment must have been performed within 4 weeks of enrollment.
• Must have recovered from toxicities due to prior therapies to Grade ≤ 2 according to the NCI CTCAE v5.0 criteria or to the subject's prior baseline.
• Must have an ECOG performance status of 0 to 1. Exclusion Criteria
• Is pregnant or lactating.
• Has inadequate venous access.
• Has active hemolytic anemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), disseminated intravascular coagulation, leukostasis, or amyloidosis.
• Concurrent or previous other malignancy within 2 years of study entry, except curatively treated malignancies including basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, breast, or Bowen's disease. Patients with other curatively treated malignancies with low risk of recurrence not listed may also be considered eligible after review and approval by the Sponsor medical monitor.
• Has active autoimmune disease, such as psoriasis, multiple sclerosis, lupus, rheumatoid arthritis, etc. (the medical monitor will determine if a disease is active and autoimmune).
• Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, primary CNS lymphoma, etc. (the medical monitor will determine if significant).
• Has an active systemic infection (e.g., causing fevers or requiring antimicrobial treatment).
• Has a history of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. Subjects with a history of treated hepatitis C can be enrolled if negative by hepatitis C polymerase chain reaction (PCR) on multiple occasions and with medical monitor approval.
• Is positive for human herpes virus (HHV)-6 or HHV-7 infection by PCR at the Screening Visit (subjects may be included in the study if they are HHV-6 or HHV-7 IgG antibody-positive but PCR-negative).
• Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia (e.g., atrial fibrillation, sustained \[\> 30 seconds\] ventricular tachyarrhythmias, etc.).
• Has any psychiatric or medical disorder (e.g., cardiovascular, endocrine, renal, gastrointestinal, genitourinary, immunodeficiency or pulmonary disorder not otherwise specified) that would, in the opinion of the Investigator or medical monitor, preclude safe participation in and/or adherence to the protocol (including medical conditions or laboratory findings that indicate a significant probability of not qualifying for or being unable to undergo, LD chemotherapy and/or CAR-T cell administration).
• Has received non-mAb anti-cancer medications within 2 weeks of the time of initiating LD chemotherapy.
• Has received mAb therapy within 4 weeks of initiating LD chemotherapy.
• Has received immunosuppressive medications within 2 weeks of the time of administration of P-CD19CD20-ALLO1, and/or expected to require them while on study (the medical monitor will determine if a medication is considered immunosuppressive.)
• Has received systemic corticosteroid therapy \> 5 mg/day of prednisone or equivalent dose of another corticosteroid within 1 week or 5 half-lives (whichever is shorter) of the administration of P-CD19CD20-ALLO1 or is expected to require it during the course of the study. (Topical and inhaled steroids are permitted. Systemic corticosteroids are contraindicated after receiving P-CD19CD20-ALLO1 cells outside of study-specific guidance or medical monitor approval).
• Has CNS metastases or CNS involvement (including leptomeningeal carcinomatosis, cranial neuropathies or mass lesions, cauda equina syndrome, and spinal cord compression).
• Has a history of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Has a history of having undergone allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. Subjects with prior history of allogeneic stem cell transplant may be enrolled if they are not on immunosuppressive medications and with medical monitor approval.
• Has received prior allogeneic genetically modified cellular therapy or was treated with experimental allogeneic cell therapy.
• History or Grade ≥ 3 HLH/MAS or neurotoxicity with prior therapies (all symptoms of HLH/MAS, neurotoxicity, or CRS from prior therapies must be resolved at the time of enrollment).
• Has positive DAT at Screening Visit (may be allowed with medical monitor approval).
BIOLOGICAL: P-CD19CD20-ALLO1, DRUG: Rimiducid
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (tFL), Follicular Lymphoma Grade 3B
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy (BeadsvsVac)
Heather Phipps, MPS - hphipps@som.umaryland.edu
ALL
18 years and over
PHASE3
NCT05615844
The inclusion criteria are:
• Patients 18 years of age or older.
• Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
• Planned internal or external fixation for definitive fracture management.
• Formal surgical debridement within 72 hours of their injury.
• Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
• Informed consent obtained. The exclusion criteria are:
• Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).
• Medical contraindication to antibiotic beads.
• Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.
• Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
• Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
• Incarceration.
• Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
• Currently enrolled in a study that does not permit co-enrollment.
• Unable to obtain informed consent due to language barriers.
• Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
• Prior enrollment in the trial.
• Other reason to exclude the patient, as approved by the Methods Center.
• Patients 18 years of age or older.
• Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
• Planned internal or external fixation for definitive fracture management.
• Formal surgical debridement within 72 hours of their injury.
• Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
• Informed consent obtained. The exclusion criteria are:
• Due to the severity of injury, the treating surgeon does not believe limb salvage \>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).
• Medical contraindication to antibiotic beads.
• Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.
• Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
• Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
• Incarceration.
• Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
• Currently enrolled in a study that does not permit co-enrollment.
• Unable to obtain informed consent due to language barriers.
• Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
• Prior enrollment in the trial.
• Other reason to exclude the patient, as approved by the Methods Center.
DRUG: Antibiotic Cement Bead Pouch, DEVICE: Negative Pressure Wound Therapy
Open Tíbia Fracture
Global Paradise System US Post Approval Study (US GPS)
Regina Maharajh - Regina.Maharajh3@prismahealth.org
ALL
18 years and over
NCT06297291
Inclusion Criteria:
* Signed and dated study informed consent
* Documented history of hypertension
* Documented history of prior or current antihypertensive medication(s)
* Mean seated office systolic BP at screening ≥ 140 mmHg
* Mean pre-procedure home systolic BP of ≥ 135 mmHg
* Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2
RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.
Exclusion Criteria:
Patients who meet the following will be excluded from participation:
* Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
* Patient under the age of 18 years old at the time of consent
* Patient is pregnant
* Patients with transplanted kidney
* Presence of abnormal kidney (or secreting adrenal) tumors
To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:
* Renal arteries with diameter \< 3mm and \> 8mm
* Renal artery with fibromuscular dysplasia (FMD)
* Stented renal artery
* Renal artery aneurysm
* Renal artery diameter stenosis \>30%
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter DEVICE: Paradise Ultrasound Renal Denervation Treatment
Hypertension, Cardiovascular Diseases, Vascular Diseases
Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Renal Denervation, Ultrasound Renal Denervation
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
IRB@prismahealth.org
FEMALE
45 years to 74 years old
PHASE3
NCT03233191
Inclusion Criteria:
* Women of childbearing potential must not be known to be pregnant or lactating
* Patients must be scheduled for, or have intent to schedule, a screening mammogram
* Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol.
* Patients must be willing and able to provide a written informed consent
* Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
* Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
* Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
* Patients must not have breast enhancements (e.g., implants or injections)
* ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
* To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
* Patients are pre-menopausal; OR
* Post-menopausal aged 45-69 with any of the following three risks factors:
* Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
* Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
* Currently on hormone therapy; OR
* Post-menopausal ages 70-74 with either of the following two risk factors:
* Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
* Currently on hormone therapy
* Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
* All other postmenopausal women are eligible for inclusion in the biennial screening regimen
* For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
* Breast density will be determined by prior mammography reports, when available; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report PROCEDURE: Digital Mammography, PROCEDURE: Digital Tomosynthesis Mammography, OTHER: Laboratory Biomarker Analysis
Breast Screening
Digital Mammography, Breast Tomography, Screening Mammography, TMIST
Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
Erica Robinson, MD - erica.robinson@prismahealth.org
FEMALE
18 years and over
PHASE3
NCT05394662
Inclusion Criteria:
• Premenopausal
• Candidate for one of the following hysteroscopic procedures:
• Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
• Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease
• Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
• Subject is willing to undergo an SLH at the Week 8 visit.
• Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
• Subject has signed the IRB/EC approved informed consent
Exclusion Criteria:
• Postmenopausal
• IUD present at time of TCGP (unless removed before or during procedure)
• Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
• Planned intrauterine interventions post-TCGP through the Week 8 visit.
• Recent intrauterine surgery within 6 weeks before the planned study procedure.
• Pregnant (positive pregnancy test) or lactating.
• Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies.
• Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection.
• Use of systemic corticosteroids within 1 week of study procedure.
• Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
• Known allergy to FD\&C No.1 dye or polyethylene glycol (PEG).
• Known clotting defects or bleeding disorders.
• Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
• Participating or considering participation in a clinical trial of another investigational drug or device during this study.
DEVICE: Juveena Hydrogel System
Intrauterine Adhesion
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
ALL
18 years and over
PHASE3
NCT06191744
Inclusion Criteria:
* Diagnosis of follicular lymphoma (FL).
* Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
* Are willing and able to comply with procedures required in the protocol.
* Must have stage, II, III or IV disease.
* Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Has one or more target lesions:
* A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
* \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
* Have laboratory values meeting the criteria in the protocol.
Exclusion Criteria:
* Had major surgery within 4 weeks prior to randomization.
* Have active cytomegalovirus (CMV) disease. DRUG: Epcoritamab, DRUG: Prednisone, DRUG: Rituximab, DRUG: Lenalidomide, DRUG: Doxorubicin, DRUG: Vincristine, DRUG: Cyclophosphamide, DRUG: Obinutuzumab, DRUG: Bendamustine
Follicular Lymphoma (FL)
Follicular Lymphoma (FL), Non-Hodgkin's lymphoma (NHL), Lymphoma, Cancer, Epcoritamab, Rituximab, Lenalidomide, Chemoimmunotherapy (CIT), Obinutuzumab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Bendamustine (Benda), R-CHOP, G-CHOP, R-Benda, G-Benda, EPCORE™FL-2