Study of Bleximenib Added to Standard Chemotherapy for Adults with Newly Diagnosed Acute Myeloid Leukemia Having NPM1 or KMT2A Gene Mutations

What this Trial Is About

Researchers are evaluating the addition of bleximenib to standard chemotherapy for adults with newly diagnosed acute myeloid leukemia AML who have specific genetic mutations in the NPM1 or KMT2A genes. This phase 3, randomized, double-blind, placebo-controlled trial aims to see if bleximenib can improve treatment outcomes compared to chemotherapy alone. The study includes patients eligible for intensive chemotherapy and focuses on those with DNA changes in their leukemia cells. Participants will receive standard chemotherapy combined with either bleximenib or a placebo. Treatment includes remission induction and consolidation therapy, followed by maintenance therapy with either bleximenib or placebo depending on the group. Treatment will continue until disease progression, unacceptable side effects, or other criteria require stopping. The study involves three groups one receiving bleximenib throughout, one receiving bleximenib during initial therapy and placebo for maintenance, and one receiving placebo throughout. Participants will be monitored for up to 4 years and 5 months to assess event-free survival, with additional follow-up up to nearly 8 years to evaluate overall survival and remission rates. Researchers will collect data on treatment response, remission duration, and the number of participants undergoing stem cell transplants. Safety and long-term outcomes will be observed to understand the effects of adding bleximenib to standard therapy.

Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)