Tests bleximenib with chemotherapy in newly diagnosed acute myeloid leukemia
Tests bleximenib added to chemotherapy in adults with NPM1 or KMT2A gene changes.
Plain-language title generated from the registry record
Registry title: Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old are you?
- Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
- Has your doctor said you cannot have intensive chemotherapy (very strong chemotherapy given in hospital)?
- Has a lab test of your blood or bone marrow found one of these gene changes in your leukemia?
- Do you have serious heart disease, such as a recent heart attack or heart failure?
Source: NCT07223814, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkNot yet recruiting
- Region MidtjyllandAarhus N, DenmarkNot yet recruiting
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
- Odense University HospitalOdense C, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Trial code
- NCT07223814EU 2025-522767-15-00
- Record updated
- 6 November 2026
- Original description
The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation.Read full original descriptionShow less
Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study
The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation.
Bleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die.
The main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes.
This is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given.
After the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared.
875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.
Inclusion: ≥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; 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; Considered eligible for intensive chemotherapy; WHO/ECOG performance status ≤2; Adequate renal and hepatic functions prior to randomization.
Exclusion: Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents; Recipient of solid organ transplant; Chronic respiratory disease requiring supplemental oxygen; Cardiac disease:; 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; QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted; Left ventricular ejection fraction (LVEF) <40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment; Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2; Known active leukemic involvement of the central nervous system (CNS).