Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
18 Years and older, Male and Female
HOVON 181 AML (primary)
NCI-2026-03507
2025-522767-15-00
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
- =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.
Treatment Sites in Georgia
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