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Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
Sponsor: Montefiore Medical Center
Summary
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.
Official title: Phase 1B Study of Venetoclax in Combination With Standard Intensive Chemotherapy With Daunorubicin Plus Cytarabine Followed by High-Dose Cytarabine in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia and Advanced Myelodysplastic Syndrome
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2022-05-25
Completion Date
2028-12
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Venetoclax Oral Tablet
Given PO
Daunorubicin
Given IV
Cytarabine
Given IV
Locations (1)
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States