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OncoMatch/Clinical Trials/NCT03319901

Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory ALL

Is NCT03319901 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Venetoclax and Standard Chemotherapy for leukemia.

Phase 1/2RecruitingDana-Farber Cancer InstituteNCT03319901Data as of May 2026

Treatment: Venetoclax · Standard Chemotherapy — This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: * Venetoclax * Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Excluded: BCR fusion

Ph-positive ALL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: venetoclax (venetoclax)

Prior treatment with venetoclax

Lab requirements

Kidney function

Creatinine clearance >50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or MDRD formula)

Liver function

Serum total bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease; ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement

Cardiac function

Ejection fraction <40% excluded; NYHA class 3-4, unstable angina/stroke/MI within 6 months excluded

Adequate organ function: Serum total bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease; ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement; Creatinine clearance >50 mL/min. Patients with active heart disease (NYHA class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months); Patients with a cardiac ejection fraction <40% excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Chicago · Chicago, Illinois
  • Massachusetts General Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • MD Anderson Cancer Center · Houston, Texas
  • Intermountain LDS Hospital · Salt Lake City, Utah

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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