Taking people in JapanPhase 3
Tests bleximenib with venetoclax and azacitidine for newly diagnosed acute myeloid leukemia
Tests bleximenib with venetoclax and azacitidine in adults newly diagnosed with acute myeloid leukemia.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Bunkyō City, Fukuoka, Fukushima, Gifu, Kanazawa, Kobe, Kumamoto, Maebashi, Nagoya, Okayama, Osaka, Sapporo, Sendai, Tokyo, Tsukuba, Yamagata, and Yoshida, JapanSee the 17 sitesAlso in 25 other countries, 253 sites
- Trial code
- Registry title
- A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 600 people, planned
- Started
- 4 Jun 2025
- Expected to end
- 15 Aug 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Bleximenib
- Venetoclax (VEN)
- Azacitidine (AZA)
- Placebo
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) with a KMT2A gene rearrangement or an NPM1 gene mutation, who cannot have intensive chemotherapy.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML with 10% or more blasts in the bone marrow. Must be unable to have intensive chemotherapy, as set out in the record.
- Earlier treatment
- No previous treatment for this leukemia.
- Biomarker or test result
- KMT2A gene rearrangement or NPM1 gene mutation.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Active leukemia in the central nervous system
- Solid organ transplant
- Heart problems such as a heart attack or heart failure within 6 months of randomization
- Active infectious hepatitis
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Be 18 years of age or older at the time of informed consent
- Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
- Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
- Participants must have adequate hepatic and renal function
- A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
- A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
- Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Who cannot take part
- Recipient of solid organ transplant
- Live, attenuated vaccine within 4 weeks of randomization
- Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
- Active infectious hepatitis
- Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients
- Diagnosis of acute promyelocytic leukemia (APL)
- Known active leukemic involvement of the central nervous system (CNS)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old are you?
- Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
- Has your doctor said you cannot have intensive chemotherapy (very strong chemotherapy given in hospital)?
- Has a lab test of your blood or bone marrow found one of these gene changes in your leukemia?
- Do you have serious heart disease, such as a recent heart attack or heart failure?
Where in Japan
Also in 25 other countries, 253 sites
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalBunkyō City, JapanTaking people
- Kyushu University HospitalFukuoka, JapanTaking people
- Fukushima Medical University HospitalFukushima, JapanTaking people
- Gifu Municipal HospitalGifu, JapanTaking people
- Kanazawa University HospitalKanazawa, JapanTaking people
- Kobe City Medical Center General HospitalKobe, JapanTaking people
- National Hospital Organization Kumamoto Medical CenterKumamoto, JapanTaking people
- Gunmaken Saiseikai Maebashi HospitalMaebashi, JapanTaking people
- Nagoya University HospitalNagoya, JapanTaking people
- Okayama University HospitalOkayama, JapanTaking people
- Japanese Red Cross Osaka HospitalOsaka, JapanTaking people
- Aiiku HospitalSapporo, JapanTaking people
- Tohoku University HospitalSendai, JapanTaking people
- Nippon Medical School HospitalTokyo, JapanTaking people
- University of Tsukuba HospitalTsukuba, JapanTaking people
- Yamagata University HospitalYamagata, JapanTaking people
- University of Fukui HospitalYoshida, JapanTaking people
About the trial
What the trial wants to find out
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
The 2 groups in the trial
- Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)Treatment being tested
Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.
Treatment: Bleximenib, Venetoclax (VEN), and Azacitidine (AZA)
- Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)Placebo, for comparison
Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.
Treatment: Venetoclax (VEN), Azacitidine (AZA), and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy
- Plain-language title
- Tests bleximenib with venetoclax and azacitidine for newly diagnosed acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06852222, who can take part
- Record updated
- 3 November 2026