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

Plain-language summary

This study evaluates Bleximenib, given with standard induction and consolidation chemotherapy (Cytarabine and Daunorubicin or Idarubicin) followed by maintenance, compared with placebo in patients with acute myeloid leukemia (AML). It enrolls newly diagnosed AML patients aged 18 and older with a mutated NPM1 or a KMT2A rearrangement who are eligible for intensive chemotherapy. The study is in Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Intervention

Bleximenib, Cytarabine, Daunorubicin or Idarubicin, Placebo

Start date

3/1/2026

Estimated completion

12/1/2033

Countries

United States, Australia, Belgium, Finland, Germany, Japan, Netherlands, Sweden

Related genes

Locations

• San Francisco, United States
• Atlanta, United States
• Kansas City, United States
• Baltimore, United States
• St Louis, United States
• Cincinnati, United States
• Adelaide, Australia
• Adelaide, Australia
• Birtinya, Australia
• Brisbane, Australia
• Camperdown, Australia
• Melbourne, Australia
• Melbourne, Australia
• Sydney, Australia
• Antwerp, Belgium
• Charleroi, Belgium
• Geel, Belgium
• Ghent, Belgium
• Jolimont, Belgium
• Liège, Belgium
• Liège, Belgium
• Yvoir, Belgium
• Oulu, Finland
• Bochum, Germany
• Greifswald, Germany
• Passau, Germany
• Ulm, Germany
• Nagasaki, Japan
• Amersfoort, Netherlands
• Amsterdam, Netherlands
• Amsterdam, Netherlands
• Arnhem, Netherlands
• Breda, Netherlands
• Dordrecht, Netherlands
• Eindhoven, Netherlands
• Groningen, Netherlands
• Leeuwarden, Netherlands
• Leiden, Netherlands
• Nieuwegein, Netherlands
• Nijmegen, Netherlands

+3

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.