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AzTrials

Acute Myeloid LeukemiaPhase 3NCT07223814

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

A Phase 3 study testing Bleximenib, Cytarabine and Daunorubicin or Idarubicin in people with Acute Myeloid Leukemia, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 108 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Bleximenib, Cytarabine and Daunorubicin or Idarubicin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
875 participants
Where
108 sitesin 13 countries
Study dates
1 Mar 2026to Dec 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.

Who cannot join

  • Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
  • Known active leukemic involvement of the central nervous system (CNS).
  • Recipient of solid organ transplant.
  • 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.
Show all 9Show fewer
  • 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.
  • Chronic respiratory disease requiring supplemental oxygen.

Trial locations and contacts

108 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

M.H.G.P. Raaijmakers contact

010 7033740

m.h.g.raaijmakers@erasmusmc.nl

108 sites in 13 countries

Netherlands18 sites, 18 recruiting

  • NL-Den Bosch-JBZ

    's-Hertogenbosch

    A. Herbers

    Recruiting

  • NL-Amersfoort-MEANDERMC

    Amersfoort

    M.F. Corsten

    Recruiting

  • NL-Amsterdam-AMSTERDAMUMC

    Amsterdam

    D.C. de Leeuw

    Recruiting

  • NL-Amsterdam-OLVG

    Amsterdam

    H. Mooij

    Recruiting

  • NL-Arnhem-RIJNSTATE

    Arnhem

    M. Cuipers

    Recruiting

  • NL-Breda-AMPHIA

    Breda

    R. Fiets

    Recruiting

  • NL-Dordrecht-ASZ

    Dordrecht

    P. Westerweel

    Recruiting

  • NL-Eindhoven-MAXIMAMC

    Eindhoven

    L. Tick

    Recruiting

  • NL-Groningen-UMCG

    Groningen

    G. Huls

    Recruiting

  • NL-Leeuwarden-FRISIUSMC

    Leeuwarden

    B. Franken

    Recruiting

  • NL-Leiden-LUMC

    Leiden

    J.H. Veelken

    Recruiting

  • NL-Maastricht-MUMC

    Maastricht

    C.H.M.J. van Elssen

    Recruiting

  • NL-Nieuwegein-ANTONIUS

    Nieuwegein

    M. Söhne

    Recruiting

  • NL-Nijmegen-RADBOUD

    Nijmegen

    F. in 't Hout

    Recruiting

  • NL-Rotterdam-ERASMUCMC

    Rotterdam

    M.H.G. Raaijmakers

    Recruiting

  • NL-Den Haag-HAGA

    The Hague

    D. Lammeren, van-Venema

    Recruiting

  • NL-Utrecht-UMCUTRECHT

    Utrecht

    L. van Hussen-Daenen

    Recruiting

  • NL-Zwolle-ISALA

    Zwolle

    T. de Waal

    Recruiting

Other trials in Netherlands

Germany16 sites, 16 recruiting

  • DE-Aachen-UKAACHEN

    Aachen

    M. Chrysandt

    Recruiting

  • DE-Bochum-RUB

    Bochum

    R. Schroers

    Recruiting

  • DE-Bonn-UNIBONN

    Bonn

    L. Teichmann

    Recruiting

  • DE-Braunschweig-KLINIKUMBRAUNSCHWEIG

    Braunschweig

    C. Schünemann

    Recruiting

  • DE-Greifswald-UNIGREIFSWALD

    Greifswald

    J. Krönke

    Recruiting

  • DE-Halle-UMH

    Halle

    M. Heuser

    Recruiting

  • DE-Hamburg-ASKLEPIOSSTGEORG

    Hamburg

    A. Elmaagacli

    Recruiting

  • DE-Hannover-MHHANNOVER

    Hanover

    F. Thol

    Recruiting

  • DE-Heilbronn-SLK

    Heilbronn

    M. Lindauer

    Recruiting

  • DE-Homburg-UNIKLINIKSAARLAND

    Homburg

    J. Bittenbring

    Recruiting

  • DE-Karlsruhe-KLINIKUMKARLSRUHE

    Karlsruhe

    M. Ringhoffer

    Recruiting

  • DE-Mainz-UNIMEDIZINMAINZ

    Mainz

    M. Kühn

    Recruiting

  • DE-Oldenburg-KLINIKUMOLDENBURG

    Oldenburg

    A. Voß

    Recruiting

  • DE-Passau-KLINIKUMPASSAU

    Passau

    T. Suedhoff

    Recruiting

  • DE-Rostock-MUROSTOCK

    Rostock

    F. Theis

    Recruiting

  • DE-Ulm-UNIKLINKULM

    Ulm

    H. Döhner

    Recruiting

Other trials in Germany

Belgium14 sites, 14 recruiting

  • BE-Antwerpen-UZA

    Antwerp

    E. de Backer

    Recruiting

  • BE-Antwerpen-ZAS

    Antwerp

    D. Breems

    Recruiting

  • BE-Brugge-AZBRUGGE

    Bruges

    T. Lodewyck

    Recruiting

  • BE-Brussel-BORDET

    Brussels

    S. Wittnebel

    Recruiting

  • BE-Bruxelles-STLUC

    Brussels

    M.C. Vekemans

    Recruiting

  • Be-Charleroi-GHDC

    Charleroi

    V. Robin

    Recruiting

  • BE-Geel-STDIMPNA

    Geel

    U. Douven

    Recruiting

  • BE-Gent-UZGENT

    Ghent

    T. De Corte

    Recruiting

  • BE-Hasselt-VIRGAJESSE (Jessa Ziekenhuis)

    Hasselt

    L. Lammertijn

    Recruiting

  • BE-Haine-Saint-Paul-JOLIMONT

    Jolimont

    R. Lattenist

    Recruiting

  • BE-Leuven-UZLEUVEN

    Leuven

    J. Maertens

    Recruiting

  • BE-Liege-CHULIEGE

    Liège

    A. De Voeght

    Recruiting

  • BE-Liege-MONTLEGIA

    Liège

    Q. Perlot

    Recruiting

  • BE-Yvoir-MONTGODINNE

    Yvoir

    E. Collinge

    Recruiting

Other trials in Belgium

United States13 sites, 13 recruiting

  • US-Atlanta GA-EMORY

    Atlanta, Georgia, 30322

    W. Blum

    Recruiting

  • US-Baltimore MD-UMGCCC

    Baltimore, Maryland, 21201

    M. Baer

    Recruiting

  • US-Charlotte NC-NOVANTCHARLOTTE

    Charlotte, North Carolina, 28204

    J. Dugan

    Recruiting

  • US-Chigago IL-UHCHICAGO

    Chicago, Illinois, 60637

    W. Stock

    Recruiting

  • US-Cincinnati OH-CINCY

    Cincinnati, Ohio, 45219

    E. Curran

    Recruiting

  • US-Colombus OH-OSU

    Columbus, Ohio, 43210

    S. Handa

    Recruiting

  • US-Kansas City KS-KUMC

    Kansas City, Kansas, 66103

    T. Lin

    Recruiting

  • US-Los Angeles CA-UCLA

    Los Angeles, California, 90095

    G. Schiller

    Recruiting

  • US-Orlando FL-ORLANDOHEALTH

    Orlando, Florida, 32806

    J. Varela

    Recruiting

  • US-Pittsburgh PA-PITT

    Pittsburgh, Pennsylvania, 15260

    A. Im

    Recruiting

  • US-San Francisco CA-UCSF

    San Francisco, California, 94115

    R. Olin

    Recruiting

  • US-St Louis MO-WASHU

    St Louis, Missouri, 63110

    G. Uy

    Recruiting

  • US-Winston-Salem NC-NOVANTWINSTON

    Winston-Salem, North Carolina, 27103

    J. Dugan

    Recruiting

Other trials in United States

Australia11 sites, 11 recruiting

  • AU-Adelaide-FLINDERS

    Adelaide

    A. Beligaswatte

    Recruiting

  • AU-Adelaide-RAH

    Adelaide

    D. Hiwase

    Recruiting

  • AU-Birtinya-SUNSHINECOAST

    Birtinya

    J. Conn

    Recruiting

  • AU-Brisbane-PAH

    Brisbane

    M. Harwood

    Recruiting

  • AU-Brisbane-RBWH

    Brisbane

    C. McNamara

    Recruiting

  • AU-Camperdown-RPA

    Camperdown

    D. Mc Culloch

    Recruiting

  • AU-Melbourne-AUSTIN

    Melbourne

    C.Y. Fong

    Recruiting

  • AU-Melbourne-MONASH

    Melbourne

    C.C. Chua

    Recruiting

  • AU-Melbourne-PMCC

    Melbourne

    A. Wei

    Recruiting

  • AU-Sydney-RNSH

    Sydney

    J. Othman

    Recruiting

  • AU-Sydney-WSAH

    Sydney

    L. Vaughan

    Recruiting

Other trials in Australia

Japan9 sites, 9 recruiting

  • JP-Bunkyo-Ku-NIPPON

    Bunkyō City

    H. Yamaguchi

    Recruiting

  • JP-Chuo-Ku-CHIBA

    Chūōku

    E. Sakaida

    Recruiting

  • JP-Maebashi-Shi-GUNMA

    Maebashi

    S. Takada

    Recruiting

  • JP-Nagasaki Shi-NAGASAKI

    Nagasaki

    K. Ando

    Recruiting

  • JP-Nagoya-shi-JRC

    Nagoya

    T. Goto

    Recruiting

  • JP-Okayama City-OKAYAMA

    Okayama

    H. Fujiwara

    Recruiting

  • JP-Tokushima Shi-TOKU

    Tokushima

    K. Matsuoka

    Recruiting

  • JP-Nishi-Gun-YAMAGATA

    Yamagata

    H. Yokoyama

    Recruiting

  • JP-Yoshida-Gun-FUKUI

    Yoshida

    T. Yamauchi

    Recruiting

Other trials in Japan

Spain6 sites, 6 recruiting

  • ES-Barcelona-MUTUATERRASSA

    Barcelona

    F. Vall-Llovera Calmet

    Recruiting

  • ES-Barcelona-PARCDESALUTMAR

    Barcelona

    S. Garcia Avila

    Recruiting

  • ES-Barcelona-SANTPAU

    Barcelona

    A. Garrido

    Recruiting

  • ES-Lleida-ICSVILANOVA

    Lleida

    A. Garcia Guinon

    Recruiting

  • ES-Palma-HSLL

    Palma de Mallorca

    A. Cladera Serra

    Recruiting

  • ES-Palma-SSIB

    Palma de Mallorca

    A. Sampol

    Recruiting

Other trials in Spain

Switzerland6 sites, 6 recruiting

  • CH-Basel-USB

    Basel

    J. van den Berg

    Recruiting

  • CH-Bern-INSEL

    Bern

    T. Pabst

    Recruiting

  • CH-Fribourg-HFR

    Fribourg

    A. Efthymiou

    Recruiting

  • CH-Geneve (14)-HCUGE

    Geneva

    Y. Beaeuverd

    Recruiting

  • CH-St. Gallen-KSSG

    Sankt Gallen

    M. Schittenhelm

    Recruiting

  • CH-Zürich-USZ

    Zurich

    A. Theocharides

    Recruiting

Other trials in Switzerland

Finland5 sites, 5 recruiting

  • FI-Helsinki-HUS

    Helsinki

    M. Kontro

    Recruiting

  • FI-Kuopio-KYS

    Kuopio

    A. Turunen

    Recruiting

  • FI-Oulu-OYS

    Oulu

    K. Launonen

    Recruiting

  • FI-Tampere-TAYS

    Tampere

    J. Rimpiläinen

    Recruiting

  • FI-Turku-TYKS

    Turku

    P. Ettala

    Recruiting

Other trials in Finland

Norway5 sites, 5 recruiting

  • NO-Bergen-HELSEBERGEN

    Bergen

    B.J. Gjertsen

    Recruiting

  • NO-Oslo-OSLOUH

    Oslo

    A. Lenartova

    Recruiting

  • NO-Stavanger-HELSESTAVANGER

    Stavanger

    W. Majeed

    Recruiting

  • NO-Tromsø-NORTHNOORWEGEN

    Tromsø

    L.M. Leknes

    Recruiting

  • NO-Trondheim-STOLAV

    Trondheim

    A.S. von Krogh

    Recruiting

Other trials in Norway

Austria2 sites, 2 recruiting

  • AT-Feldkirch-IKHF

    Feldkirch

    B. Hartmann

    Recruiting

  • AT-Linz-ORDENSKLINIKUM

    Linz

    S. Machherndl-Spandl

    Recruiting

Other trials in Austria

Estonia2 sites, 2 recruiting

  • EE-Tallinn-REGIONAALHAIGLA

    Tallinn

    K. Palk

    Recruiting

  • EE-Tartu-TARTU

    Tartu

    A. Kaare

    Recruiting

Other trials in Estonia

Sweden1 site, 1 recruiting

  • SE-Lund-Suh

    Lund

    V. Lazarevic

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

Read more

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.

Being tested
Bleximenib, Cytarabine, Daunorubicin or Idarubicin, Placebo
Keywords
AML, adult, newly diagnosed AML, NPM1, KMT2A
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BleximenibDrug

    Participants will receive bleximenib

  • CytarabineDrug

    Participants will receive Cytarabine

  • Daunorubicin or IdarubicinDrug

    Participants will receive Daunorubicin or Idarubicin

  • PlaceboDrug

    Participants will receive Placebo

Study groups in NCT07223814
Study groupRoleWhat they receive
Arm 1: Standard of care treatment plus bleximenib and also maintenance treatment with bleximenibExperimentalBleximenib in combination with remission induction and consolidation therapy, followed by bleximenib maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)
Receives: Drug: Bleximenib; Drug: Cytarabine; Drug: Daunorubicin or Idarubicin
Arm 2: Standard of care treatment plus bleximenib and maintenance treatment with a placebo.ExperimentalBleximenib in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy. Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)
Receives: Drug: Bleximenib; Drug: Cytarabine; Drug: Daunorubicin or Idarubicin; Drug: Placebo
Arm 3: Standard of care treatment plus a placebo and maintenance treatment with a placebo.Placebo comparatorPlacebo comparator in combination with remission induction and consolidation therapy, followed by placebo maintenance therapy . Treatment will continue until PD, unacceptable toxicity or other protocol defined criteria for discontinuation (whichever comes first)
Receives: Drug: Cytarabine; Drug: Daunorubicin or Idarubicin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy

    To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction chemotherapy, prolongs event-free survival (EFS) measured from the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first.

    Measured: Up to 4 years and 5 months

Secondary outcomes (4)

  1. Overall Survival (OS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy

    To assess if treatment with bleximenib, as compared with placebo, in combination with remission induction and consolidation chemotherapy, followed by maintenance therapy, prolongs overall survival (OS) measured from randomization to death due to any cause.

    Measured: Up to 7 years and 10 months

  2. Rates of CR, CRh, CRi in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy

    Defined as the proportion of participants achieving a given response after induction cycle 1 and after induction cycle 2.

    Measured: Up to 7 years and 10 months

  3. Prolongation of CR (DoCR) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy

    Defined as the time from achieving first response of CR to hematologic relapse or death from any cause, whichever occurs first.

    Measured: Up to 4 years and 5 months

  4. Percentage of participants undergoing an allo-SCT in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy

    To assess the percentage of participants undergoing an allo-SCT as part of protocol treatment

    Measured: Up to 7 years and 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2025
  2. Study start1 Mar 2026
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
875 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223814
Sponsor's protocol ID
HOVON 181 AML
Other IDs
2025-522767-15-00, 2025
Status last verified
Nov 2026
First submitted
30 Oct 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the current publication policy the protocol and Statistica! Analysis Plan ( SAP) will be shared. The principal lnvestigators can be contacted for IPD sharing after the publication of the study results. According to 'HOVON sample and/or Data request Form' theHOVON director; chair of theHOVON Acute Myeloid Leukemie working group, the study PI and Coordinating lnvestigator should approve data/sample sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bleximenib, Cytarabine and Daunorubicin or Idarubicin in people with Acute Myeloid Leukemia, run by Stichting Hemato-Oncologie voor Volwassenen Nederland at 108 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Netherlands, Germany, Belgium, United States, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact M.H.G.P. Raaijmakers (010 7033740, m.h.g.raaijmakers@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy (time frame: Up to 4 years and 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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