Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

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

Trial Details

NCT ID
NCT05342584
Phase
PHASE1
Sponsor
Montefiore Medical Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax Oral Tablet
  • Daunorubicin
  • Cytarabine
Locations (sample)
  • The Bronx, New York, United States|40.84985,-73.86641

Key Eligibility 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-…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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