🏛️ Verified NIH Record • Updated 2026-07-16
Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (NCT03504644)
🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: ECOG-ACRIN Cancer Research Group
🩺 Plain-English Summary (8th-Grade Level)
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (32 items) and avoid the listed exclusions (29 items).
Location: Anchorage Associates in Radiation Medicine — Anchorage, Alaska
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients of childbearing potential must not be pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with isolated testicular or central nervous system (CNS) relapsed disease are not eligible
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have Burkitt's lymphoma/leukemia based on the World Health Organization (WHO) criteria
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or the use of CNS-directed local treatment for active disease within the prior 28 days; prophylactic intrathecal chemotherapy is allowed; previously treated CNS disease with documented clearance of the CSF will be allowed
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients will not be enrolled if they received prior chemotherapy within 2 weeks before registration to step 1 with the following exceptions: to reduce the circulating lymphoblast count or palliation or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients cannot have poorly controlled chronic viral infections including hepatitis B, C, or human immunodeficiency virus (HIV); HIV positive patients are allowed on this study if they have a CD4 count \>= 400, and are on a stable antiviral regimen
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients must not be taking any other experimental medications within 21 days prior to registration. Clinical trial medications that are Food and Drug Administration (FDA) approved will be allowed within 14 days prior to registration
- ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C) - STEP 1: Patients should not have received the following within 7 days prior to the first dose of study drug:
- Strong and moderate CYP3A inhibitors;
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (170 Sites)
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Anchorage Radiation Therapy Center — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- University of Florida Health Science Center - Jacksonville — Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida
- Saint Luke's Cancer Institute - Boise — Boise, Idaho
- Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho
- Saint Luke's Cancer Institute - Meridian — Meridian, Idaho
- Saint Luke's Cancer Institute - Nampa — Nampa, Idaho
- Saint Luke's Cancer Institute - Twin Falls — Twin Falls, Idaho
- Saint Anthony's Health — Alton, Illinois
- Illinois CancerCare-Bloomington — Bloomington, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.