NCT07223814 Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
| NCT ID | NCT07223814 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stichting Hemato-Oncologie voor Volwassenen Nederland |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 875 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 875 participants in total. It began in 2026-03-01 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
M.H.G.P. Raaijmakers
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT07223814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07223814 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 875 participants.
Is NCT07223814 currently recruiting?
Yes, NCT07223814 is actively recruiting participants. Contact the research team at m.h.g.raaijmakers@erasmusmc.nl for enrollment information.
Where is the NCT07223814 trial being conducted?
This trial is being conducted at Cincinnati, United States, Ulm, Germany, Breda, Netherlands, Eindhoven, Netherlands and 4 additional locations.
Who is sponsoring the NCT07223814 clinical trial?
NCT07223814 is sponsored by Stichting Hemato-Oncologie voor Volwassenen Nederland. The principal investigator is M.H.G.P. Raaijmakers at Erasmus Medical Center. The trial plans to enroll 875 participants.
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