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 criteria:

- 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 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, blockage
of 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, or
venetoclax excipients