Last updated 47 hours ago
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML)
600 patients around the world
Available in Brazil, United States
Janssen Research & Development, LLC
3Research sites
600Patients around the world
This study is for people with
Leukemia
Acute myeloid leukemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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) 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.
- Diagnosis of acute promyelocytic leukemia (APL).Known active leukemic involvement of the central nervous system (CNS).Recipient of solid organ transplant.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 attack within 6 months of randomization.Active infectious hepatitis.Live, attenuated vaccine within 4 weeks of randomization.Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
StudycAMeLot-2
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Acute myeloid leukemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06852222
