Bleximenib with standard induction/consolidation chemotherapy followed by maintenance for newly diagnosed AML with NPM1 or KMT2A changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 trial in adults with newly diagnosed AML harboring NPM1 mutations or KMT2A rearrangements. All participants receive standard intensive induction and consolidation chemotherapy (cytarabine plus daunorubicin or idarubicin) and are randomized to receive either bleximenib or matching placebo, followed by maintenance with the assigned drug. Bleximenib is a menin inhibitor designed to disrupt menin–KMT2A interactions that drive leukemia in these genetic subtypes. The trial is conducted at multiple centers in the US, Germany, and the Netherlands and enrolls patients eligible for intensive chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.
2. New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.
3. Considered eligible for intensive chemotherapy.
4. WHO/ECOG performance status ≤2.
5. Adequate renal and hepatic functions prior to randomization.

Exclusion Criteria:

1. Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
2. Known active leukemic involvement of the central nervous system (CNS).
3. Recipient of solid organ transplant.
4. Cardiac disease:

   1. Any of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack.
   2. QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.
   3. Left ventricular ejection fraction (LVEF) \<40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.
   4. Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2.
5. Chronic respiratory disease requiring supplemental oxygen.

Where it's running

• US-Los Angeles CA-UCLA
  Los Angeles, California, United States Recruiting
• US-San Francisco CA-UCSF
  San Francisco, California, United States Recruiting
• US-Orlando FL-ORLANDOHEALTH
  Orlando, Florida, United States Recruiting
• US-Atlanta GA-EMORY
  Atlanta, Georgia, United States Recruiting
• US-Chigago IL-UHCHICAGO
  Chicago, Illinois, United States Recruiting
• US-Kansas City KS-KUMC
  Kansas City, Kansas, United States Recruiting

+58 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: M.H.G.P. Raaijmakers — Erasmus Medical Center
• Study coordinator: M.H.G.P. Raaijmakers
• Email: m.h.g.raaijmakers@erasmusmc.nl
• Phone: 010 7033740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.