Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Nowo rozpoznana białaczka szpikowa z mutacją NPM1 lub przegrupowaniem KMT2A
- •Kwalifikowalność do intensywnej chemioterapii
- •Prawidłowa funkcja nerek i wątroby
✗ Disqualifies
- •Poprzednie leczenie chemioterapią białaczki
- •Białaczka zaangażowała ośrodkowy układ nerwowy
- •Przeszczep narządu stałego
- •Zawał serca, udar lub poważne problemy z sercem w ciągu ostatnich 6 miesięcy
- •Znacznie ograniczona funkcja serca (frakcja wyrzutowa poniżej 40%)
- •Wcześniejsze leczenie antybiotykami chemoterapeutycznymi w dużych dawkach (ponad 500 mg/m2)
- •Przewlekła choroba płuc wymagająca tlenu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (43)
US-San Francisco CA-UCSF
San Francisco, United States
US-Atlanta GA-EMORY
Atlanta, United States
US-Kansas City KS-KUMC
Kansas City, United States
US-Baltimore MD-UMGCCC
Baltimore, United States
US-St Louis MO-WASHU
St Louis, United States
US-Cincinnati OH-CINCY
Cincinnati, 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-PMCC
Melbourne, Australia
AU-Sydney-WSAH
Sydney, Australia
BE-Antwerpen-ZAS
Antwerp, Belgium
Be-Charleroi-GHDC
Charleroi, Belgium
BE-Geel-STDIMPNA
Geel, Belgium
BE-Gent-UZGENT
Ghent, Belgium
BE-Haine-Saint-Paul-JOLIMONT
Jolimont, Belgium
BE-Liege-CHULIEGE
Liège, Belgium
BE-Liege-MONTLEGIA
Liège, Belgium
BE-Yvoir-MONTGODINNE
Yvoir, Belgium
FI-Oulu-OYS
Oulu, Finland
DE-Bochum-RUB
Bochum, Germany
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
DE-Passau-KLINIKUMPASSAU
Passau, Germany
DE-Ulm-UNIKLINKULM
Ulm, Germany
JP-Nagasaki Shi-NAGASAKI
Nagasaki, 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-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
Trial contact
M.H.G.P. Raaijmakers
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/15/2026.
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