A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy
Janssen Research & Development, LLC
Summary
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Be 18 years of age or older at the time of informed consent * Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (\> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria * Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) \>=18 to \<75 years of age with \>…
Interventions
- DrugBleximenib
Bleximenib will be administered orally.
- DrugVenetoclax (VEN)
VEN will be administered orally.
- DrugAzacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
- DrugPlacebo
Placebo will be administered orally.
Locations (248)
- University of Alabama at BirminghamBirmingham, Alabama
- Cancer Treatment Center of America PhoenixGoodyear, Arizona
- The University of Arizona Cancer CenterTucson, Arizona
- University of Arkansas at Little RockLittle Rock, Arkansas
- City of HopeDuarte, California
- Medical Oncology Hematology Consultants, PANewark, Delaware