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.
Plain-language title generated from the registry record
Registry title: A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Key facts
- Where
- Ankara, Antalya, Istanbul, Mersin, Sakarya, and Samsun, TürkiyeSee the 8 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06852222, who can take part
Where in Türkiye
- Ankara Etlik Sehir HastanesiAnkara, TürkiyeTaking people
- Ankara University School of Medicine Cebeci HospitalAnkara, TürkiyeTaking people
- Dr. Abdurrahman Yurtaslan Oncology Training and Research HospitalAnkara, TürkiyeTaking people
- Memorial Antalya HospitalAntalya, TürkiyeTaking people
- Koc University Medical FacultyIstanbul, TürkiyeTaking people
- VM Medical Park Mersin HospitalMersin, TürkiyeTaking people
- Sakarya University Training and Research HospitalSakarya, TürkiyeTaking people
- Ondokuz Mayis UniversitySamsun, TürkiyeTaking people
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?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06852222EU 2024-520154-38-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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).