A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Inclusion criteria:

• Be 18 years of age or older at the time of informed consent

• Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) ornucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater thanor equal to (> or =) 10% bone marrow blasts per 2022 international ConsensusClassification criteria

• Ineligible for intensive chemotherapy based on the following criteria: a) >= 75years of age and ineligible per physician's discretion, with Eastern CooperativeOncology 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) Severecardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderatehepatic impairment vi) Comorbidity that, in the investigator's opinion, makes theparticipant unsuitable for intensive chemotherapy, which must be documented beforeenrollment as defined in the protocol. Ineligibility for intensive chemotherapyshould be explicitly approved by a multidisciplinary team in countries in which thisprocess 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 becomepregnant and use protocol-specified contraception while enrolled in this study andfor 6 months after the last dose of study treatment

• A male participant must agree to use protocol-specified contraception while enrolledin 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 thepurpose of, and procedures required for, the study and is willing to participate inthe study

Exclusion criteria:

• 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, blockageof a blood vessel to brain, or transient ischemic (decreased oxygen in tissue)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, orvenetoclax excipients