OncoMatch/Clinical Trials/NCT05342584
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
Is NCT05342584 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Venetoclax Oral Tablet and Daunorubicin for acute myeloid leukemia.
Treatment: Venetoclax Oral Tablet · Daunorubicin · Cytarabine — This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
creatinine clearance > 30 mL/min based on the Cockcroft Gault equation
Liver function
total bilirubin < 1.5x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT < 3x ULN unless considered due to leukemic involvement
Cardiac function
No NYHA Class III or IV congestive heart failure or LVEF <45% by echocardiogram or MUGA scan; no history of myocardial infarction within the last 6 months or unstable/uncontrolled angina or history of severe/uncontrolled ventricular arrhythmias
Adequate renal function including creatinine clearance > 30 mL/min based on the Cockcroft Gault equation. Adequate hepatic function including total bilirubin < 1.5x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT < 3x ULN unless considered due to leukemic involvement. Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <45% by echocardiogram or multi-gated acquisition (MUGA) scan. Patients with a history of myocardial infarction within the last 6 months or unstable / uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM) · The Bronx, New York
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