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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
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
875
Start Date
2026-03-01
Completion Date
2033-12
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
Bleximenib
Participants will receive bleximenib
Cytarabine
Participants will receive Cytarabine
Daunorubicin or Idarubicin
Participants will receive Daunorubicin or Idarubicin
Placebo
Participants will receive Placebo
Locations (63)
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-Cincinnati OH-CINCY
Cincinnati, Ohio, United States
AU-Adelaide-FLINDERS
Adelaide, Australia
AU-Adelaide-RAH
Adelaide, Australia
AU-Birtinya-SUNSHINECOAST
Birtinya, Australia
AU-Brisbane-PAH
Brisbane, Australia
AU-Camperdown-RPA
Camperdown, Australia
AU-Melbourne-AUSTIN
Melbourne, Australia
AU-Melbourne-MONASH
Melbourne, Australia
AU-Melbourne-PMCC
Melbourne, Australia
AU-Sydney-WSAH
Sydney, Australia
BE-Antwerpen-UZA
Antwerp, Belgium
BE-Antwerpen-ZAS
Antwerp, Belgium
BE-Brugge-AZBRUGGE
Bruges, Belgium
BE-Brussel-BORDET
Brussels, Belgium
Be-Charleroi-GHDC
Charleroi, Belgium
BE-Geel-STDIMPNA
Geel, Belgium
BE-Gent-UZGENT
Ghent, 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-Oulu-OYS
Oulu, Finland
FI-Tampere-TAYS
Tampere, Finland
DE-Aachen-UKAACHEN
Aachen, Germany
DE-Bochum-RUB
Bochum, Germany
DE-Bonn-UNIBONN
Bonn, Germany
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
DE-Halle-UMH
Halle, Germany
DE-Hannover-MHHANNOVER
Hanover, Germany
DE-Heilbronn-SLK
Heilbronn, Germany
DE-Karlsruhe-KLINIKUMKARLSRUHE
Karlsruhe, Germany
DE-Passau-KLINIKUMPASSAU
Passau, Germany
DE-Ulm-UNIKLINKULM
Ulm, Germany
JP-Chuo-Ku-CHIBA
Chūōku, Japan
JP-Nagasaki Shi-NAGASAKI
Nagasaki, Japan
JP-Nishi-Gun-YAMAGATA
Yamagata, Japan
JP-Yoshida-Gun-FUKUI
Yoshida, Japan
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
SE-Lund-Suh
Lund, Sweden