Montefiore Medical Center
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.
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability and determine the dose-limiting toxicity and the maximum tolerated dose (MTD) of the combination of daunorubicin \& cytarabine chemotherapy plus Venetoclax for patients with AML SECONDARY OBJECTIVES: I. To assess efficacy by response per 2022 ELN and revised International Working Group (IWG) criteria. II. To determine additional response parameters: CR/CRi and CR/CRh rates. III. To determine time to response variables including overall survival (OS), event-free survival (EFS) and duration of response (DOR) EXPLORATORY OBJECTIV…
Inclusion Criteria: * New diagnosis of AML by WHO criteria. Patients with higher risk MDS (R-IPSS\>3.5) and 10% blasts or more, or proliferative (WBC ≥ 13 x 10⁹/L) CMML-2 are also eligible at the discretion of the PI. Patients having received any prior hypomethylating agent with or without BCL2 inhibitor therapy for MDS/AML are also eligible at the discretion of the PI * Patients ≥ 18 to ≤ 75 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Adequate renal function including creatinine clearance \> 30 mL/min based on the Cockcroft Gault equation. * Adequate hepati…
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Given IV
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