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New pill could boost leukemia treatment for patients with specific gene changes

NCT ID NCT07223814

Disease control Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether adding the drug bleximenib to standard chemotherapy helps adults with a certain genetic type of acute myeloid leukemia (AML). About 875 people will get either bleximenib or a placebo alongside chemo, then be followed for 4 years. The goal is to see if bleximenib delays the cancer from coming back or improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bleximenib
What this could lead to
If it works, this could lead to a new standard treatment that improves survival for people with certain genetic types of AML.
What could go wrong
This is a large phase 3 trial, but it's still experimental. Adding bleximenib may not improve outcomes over chemo alone, and side effects could be worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 875 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    82 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AT-Linz-ORDENSKLINIKUM

    RECRUITING

    Linz, Austria

  • AU-Adelaide-FLINDERS

    RECRUITING

    Adelaide, Australia

  • AU-Adelaide-RAH

    RECRUITING

    Adelaide, Australia

  • AU-Birtinya-SUNSHINECOAST

    RECRUITING

    Birtinya, Australia

  • AU-Brisbane-PAH

    RECRUITING

    Brisbane, Australia

  • AU-Brisbane-RBWH

    RECRUITING

    Brisbane, Australia

  • AU-Camperdown-RPA

    RECRUITING

    Camperdown, Australia

  • AU-Melbourne-AUSTIN

    RECRUITING

    Melbourne, Australia

  • AU-Melbourne-MONASH

    RECRUITING

    Melbourne, Australia

  • AU-Melbourne-PMCC

    RECRUITING

    Melbourne, Australia

  • AU-Sydney-WSAH

    RECRUITING

    Sydney, Australia

  • BE-Antwerpen-UZA

    RECRUITING

    Antwerp, Belgium

  • BE-Antwerpen-ZAS

    RECRUITING

    Antwerp, Belgium

  • BE-Brugge-AZBRUGGE

    RECRUITING

    Bruges, Belgium

  • BE-Brussel-BORDET

    RECRUITING

    Brussels, Belgium

  • BE-Bruxelles-STLUC

    RECRUITING

    Brussels, Belgium

  • BE-Geel-STDIMPNA

    RECRUITING

    Geel, Belgium

  • BE-Gent-UZGENT

    RECRUITING

    Ghent, Belgium

  • BE-Haine-Saint-Paul-JOLIMONT

    RECRUITING

    Jolimont, Belgium

  • BE-Hasselt-VIRGAJESSE (Jessa Ziekenhuis)

    RECRUITING

    Hasselt, Belgium

  • BE-Leuven-UZLEUVEN

    RECRUITING

    Leuven, Belgium

  • BE-Liege-CHULIEGE

    RECRUITING

    Liège, Belgium

  • BE-Liege-MONTLEGIA

    RECRUITING

    Liège, Belgium

  • BE-Yvoir-MONTGODINNE

    RECRUITING

    Yvoir, Belgium

  • Be-Charleroi-GHDC

    RECRUITING

    Charleroi, Belgium

  • CH-Bern-INSEL

    RECRUITING

    Bern, Switzerland

  • CH-Fribourg-HFR

    RECRUITING

    Fribourg, Switzerland

  • CH-Geneve (14)-HCUGE

    RECRUITING

    Geneva, Switzerland

  • CH-St. Gallen-KSSG

    RECRUITING

    Sankt Gallen, Switzerland

  • CH-Zürich-USZ

    RECRUITING

    Zurich, Switzerland

  • DE-Aachen-UKAACHEN

    RECRUITING

    Aachen, Germany

  • DE-Bochum-RUB

    RECRUITING

    Bochum, Germany

  • DE-Bonn-UNIBONN

    RECRUITING

    Bonn, Germany

  • DE-Greifswald-UNIGREIFSWALD

    RECRUITING

    Greifswald, Germany

  • DE-Halle-UMH

    RECRUITING

    Halle, Germany

  • DE-Hannover-MHHANNOVER

    RECRUITING

    Hanover, Germany

  • DE-Heilbronn-SLK

    RECRUITING

    Heilbronn, Germany

  • DE-Karlsruhe-KLINIKUMKARLSRUHE

    RECRUITING

    Karlsruhe, Germany

  • DE-Oldenburg-KLINIKUMOLDENBURG

    RECRUITING

    Oldenburg, Germany

  • DE-Passau-KLINIKUMPASSAU

    RECRUITING

    Passau, Germany

  • DE-Rostock-MUROSTOCK

    RECRUITING

    Rostock, Germany

  • DE-Ulm-UNIKLINKULM

    RECRUITING

    Ulm, Germany

  • EE-Tallinn-REGIONAALHAIGLA

    RECRUITING

    Tallinn, Estonia

  • EE-Tartu-TARTU

    RECRUITING

    Tartu, Estonia

  • ES-Palma-SSIB

    RECRUITING

    Palma de Mallorca, Spain

  • FI-Helsinki-HUS

    RECRUITING

    Helsinki, Finland

  • FI-Kuopio-KYS

    RECRUITING

    Kuopio, Finland

  • FI-Oulu-OYS

    RECRUITING

    Oulu, Finland

  • FI-Tampere-TAYS

    RECRUITING

    Tampere, Finland

  • JP-Chuo-Ku-CHIBA

    RECRUITING

    Chūōku, Japan

  • JP-Maebashi-Shi-GUNMA

    RECRUITING

    Maebashi, Japan

  • JP-Nagasaki Shi-NAGASAKI

    RECRUITING

    Nagasaki, Japan

  • JP-Nishi-Gun-YAMAGATA

    RECRUITING

    Yamagata, Japan

  • JP-Yoshida-Gun-FUKUI

    RECRUITING

    Yoshida, Japan

  • NL-Amersfoort-MEANDERMC

    RECRUITING

    Amersfoort, Netherlands

  • NL-Amsterdam-AMSTERDAMUMC

    RECRUITING

    Amsterdam, Netherlands

  • NL-Amsterdam-OLVG

    RECRUITING

    Amsterdam, Netherlands

  • NL-Arnhem-RIJNSTATE

    RECRUITING

    Arnhem, Netherlands

  • NL-Breda-AMPHIA

    RECRUITING

    Breda, Netherlands

  • NL-Den Haag-HAGA

    RECRUITING

    The Hague, Netherlands

  • NL-Dordrecht-ASZ

    RECRUITING

    Dordrecht, Netherlands

  • NL-Eindhoven-MAXIMAMC

    RECRUITING

    Eindhoven, Netherlands

  • NL-Groningen-UMCG

    RECRUITING

    Groningen, Netherlands

  • NL-Leeuwarden-FRISIUSMC

    RECRUITING

    Leeuwarden, Netherlands

  • NL-Leiden-LUMC

    RECRUITING

    Leiden, Netherlands

  • NL-Maastricht-MUMC

    RECRUITING

    Maastricht, Netherlands

  • NL-Nieuwegein-ANTONIUS

    RECRUITING

    Nieuwegein, Netherlands

  • NL-Nijmegen-RADBOUD

    RECRUITING

    Nijmegen, Netherlands

  • NL-Rotterdam-ERASMUCMC

    RECRUITING

    Rotterdam, Netherlands

  • NL-Zwolle-ISALA

    RECRUITING

    Zwolle, Netherlands

  • SE-Lund-Suh

    RECRUITING

    Lund, Sweden

  • US-Atlanta GA-EMORY

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • US-Baltimore MD-UMGCCC

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • US-Chigago IL-UHCHICAGO

    RECRUITING

    Chicago, Illinois, 60637, United States

  • US-Cincinnati OH-CINCY

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • US-Colombus OH-OSU

    RECRUITING

    Columbus, Ohio, 43210, United States

  • US-Kansas City KS-KUMC

    RECRUITING

    Kansas City, Kansas, 66103, United States

  • US-Los Angeles CA-UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • US-Orlando FL-ORLANDOHEALTH

    RECRUITING

    Orlando, Florida, 32806, United States

  • US-Pittsburgh PA-PITT

    RECRUITING

    Pittsburgh, Pennsylvania, 15260, United States

  • US-San Francisco CA-UCSF

    RECRUITING

    San Francisco, California, 94115, United States

  • US-St Louis MO-WASHU

    RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.