Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Recruiting Phase 1 Interventional Study
Acute Myeloid Leukemia Myelodysplastic Syndromes
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
99 (estimated)
Sponsor
Montefiore Medical Center · Other
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About This Trial
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 Pa…
Trial Locations
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Eligibility Criteria
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 inh…
Contacts

Ioannis Mantzaris, MD

718-920-4826

imantzar@montefiore.org

CONTACT