Bleximenib for Newly Diagnosed AML (NPM1m or KMT2Ar)
This study is testing a new drug called bleximenib in combination with standard chemotherapy (Cytarabine, Daunorubicin or Idarubicin) for adults with newly diagnosed Acute Myeloid Leukemia (AML). Bleximenib works by blocking a specific interaction in leukemia cells with mutations in the NPM1 or KMT2A genes, which can cause these cells to die. Some participants will receive a placebo instead of bleximenib. The main goal is to see if adding bleximenib improves how long patients live without their disease getting worse (Event-Free Survival). You may be able to join if you are 18 or older, have newly diagnosed AML with specific gene mutations (NPM1 or KMT2A), and are eligible for intensive chemotherapy. The study is currently recruiting 875 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. It plans to enroll 875 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for Event-Free Survival for up to 4 years and 5 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
At a glance
Conditions
Where it's being run
63 sites across 16 statesStudy leadership
- M.H.G.P. Raaijmakers · PRINCIPAL_INVESTIGATOR · Erasmus Medical Center
Who to contact
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What this trial measures
- Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapyUp to 4 years and 5 months
To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction chemotherapy, prolongs event-free survival (EFS) measured from the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first.