RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland • ClinicalTrials.gov ID: NCT07223814

Registry updated: 2026-10-08

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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. 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.

Interventions

Bleximenib (Drug)
Participants will receive bleximenib
Cytarabine (Drug)
Participants will receive Cytarabine
Daunorubicin or Idarubicin (Drug)
Participants will receive Daunorubicin or Idarubicin
Placebo (Drug)
Participants will receive Placebo

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.

Conditions

Acute Myeloid Leukemia

Locations

US-Los Angeles CA-UCLA — Los Angeles, California, United States
US-San Francisco CA-UCSF — San Francisco, California, United States
US-Orlando FL-ORLANDOHEALTH — Orlando, Florida, United States
US-Atlanta GA-EMORY — Atlanta, Georgia, United States
US-Chigago IL-UHCHICAGO — Chicago, Illinois, United States
US-Kansas City KS-KUMC — Kansas City, Kansas, United States
US-Baltimore MD-UMGCCC — Baltimore, Maryland, United States
US-St Louis MO-WASHU — St Louis, Missouri, United States
US-Charlotte NC-NOVANTCHARLOTTE — Charlotte, North Carolina, United States
US-Winston-Salem NC-NOVANTWINSTON — Winston-Salem, North Carolina, United States
US-Cincinnati OH-CINCY — Cincinnati, Ohio, United States
US-Colombus OH-OSU — Columbus, Ohio, United States
US-Pittsburgh PA-PITT — Pittsburgh, Pennsylvania, United States
AU-Adelaide-FLINDERS — Adelaide, Australia
AU-Adelaide-RAH — Adelaide, Australia
AU-Birtinya-SUNSHINECOAST — Birtinya, Australia
AU-Brisbane-PAH — Brisbane, Australia
AU-Brisbane-RBWH — Brisbane, Australia
AU-Camperdown-RPA — Camperdown, Australia
AU-Melbourne-AUSTIN — Melbourne, Australia
AU-Melbourne-MONASH — Melbourne, Australia
AU-Melbourne-PMCC — Melbourne, Australia
AU-Sydney-RNSH — Sydney, Australia
AU-Sydney-WSAH — Sydney, Australia
AT-Linz-ORDENSKLINIKUM — Linz, Austria
BE-Antwerpen-UZA — Antwerp, Belgium
BE-Antwerpen-ZAS — Antwerp, Belgium
BE-Brugge-AZBRUGGE — Bruges, Belgium
BE-Brussel-BORDET — Brussels, Belgium
BE-Bruxelles-STLUC — Brussels, Belgium
Be-Charleroi-GHDC — Charleroi, Belgium
BE-Geel-STDIMPNA — Geel, Belgium
BE-Gent-UZGENT — Ghent, Belgium
BE-Hasselt-VIRGAJESSE (Jessa Ziekenhuis) — Hasselt, Belgium
BE-Haine-Saint-Paul-JOLIMONT — Jolimont, Belgium
BE-Leuven-UZLEUVEN — Leuven, Belgium
BE-Liege-CHULIEGE — Liège, Belgium
BE-Liege-MONTLEGIA — Liège, Belgium
BE-Yvoir-MONTGODINNE — Yvoir, Belgium
EE-Tallinn-REGIONAALHAIGLA — Tallinn, Estonia
EE-Tartu-TARTU — Tartu, Estonia
FI-Helsinki-HUS — Helsinki, Finland
FI-Kuopio-KYS — Kuopio, Finland
FI-Oulu-OYS — Oulu, Finland
FI-Tampere-TAYS — Tampere, Finland
FI-Turku-TYKS — Turku, Finland
DE-Aachen-UKAACHEN — Aachen, Germany
DE-Bochum-RUB — Bochum, Germany
DE-Bonn-UNIBONN — Bonn, Germany
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG — Braunschweig, Germany
DE-Greifswald-UNIGREIFSWALD — Greifswald, Germany
DE-Halle-UMH — Halle, Germany
DE-Hamburg-ASKLEPIOSSTGEORG — Hamburg, Germany
DE-Hannover-MHHANNOVER — Hanover, Germany
DE-Heilbronn-SLK — Heilbronn, Germany
DE-Homburg-UNIKLINIKSAARLAND — Homburg, Germany
DE-Karlsruhe-KLINIKUMKARLSRUHE — Karlsruhe, Germany
DE-Oldenburg-KLINIKUMOLDENBURG — Oldenburg, Germany
DE-Passau-KLINIKUMPASSAU — Passau, Germany
DE-Rostock-MUROSTOCK — Rostock, Germany
DE-Ulm-UNIKLINKULM — Ulm, Germany
JP-Chuo-Ku-CHIBA — Chūōku, Japan
JP-Maebashi-Shi-GUNMA — Maebashi, Japan
JP-Nagasaki Shi-NAGASAKI — Nagasaki, Japan
JP-Nagoya-shi-JRC — Nagoya, Japan
JP-Nishi-Gun-YAMAGATA — Yamagata, Japan
JP-Yoshida-Gun-FUKUI — Yoshida, Japan
NL-Den Bosch-JBZ — 's-Hertogenbosch, Netherlands
NL-Amersfoort-MEANDERMC — Amersfoort, Netherlands
NL-Amsterdam-AMSTERDAMUMC — Amsterdam, Netherlands
NL-Amsterdam-OLVG — Amsterdam, Netherlands
NL-Arnhem-RIJNSTATE — Arnhem, Netherlands
NL-Breda-AMPHIA — Breda, Netherlands
NL-Dordrecht-ASZ — Dordrecht, Netherlands
NL-Eindhoven-MAXIMAMC — Eindhoven, Netherlands
NL-Groningen-UMCG — Groningen, Netherlands
NL-Leeuwarden-FRISIUSMC — Leeuwarden, Netherlands
NL-Leiden-LUMC — Leiden, Netherlands
NL-Maastricht-MUMC — Maastricht, Netherlands
NL-Nieuwegein-ANTONIUS — Nieuwegein, Netherlands
NL-Nijmegen-RADBOUD — Nijmegen, Netherlands
NL-Rotterdam-ERASMUCMC — Rotterdam, Netherlands
NL-Den Haag-HAGA — The Hague, Netherlands
NL-Utrecht-UMCUTRECHT — Utrecht, Netherlands
NL-Zwolle-ISALA — Zwolle, Netherlands
NO-Bergen-HELSEBERGEN — Bergen, Norway
NO-Oslo-OSLOUH — Oslo, Norway
NO-Trondheim-STOLAV — Trondheim, Norway
ES-Barcelona-MUTUATERRASSA — Barcelona, Spain
ES-Lleida-ICSVILANOVA — Lleida, Spain
ES-Palma-HSLL — Palma de Mallorca, Spain
ES-Palma-SSIB — Palma de Mallorca, Spain
SE-Lund-Suh — Lund, Sweden
CH-Bern-INSEL — Bern, Switzerland
CH-Fribourg-HFR — Fribourg, Switzerland
CH-Geneve (14)-HCUGE — Geneva, Switzerland
CH-St. Gallen-KSSG — Sankt Gallen, Switzerland
CH-Zürich-USZ — Zurich, Switzerland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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