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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT06852222

Run by

Janssen Research & Development, LLC

People needed

600

Starts

2025-06-04

Expected to finish

2029-08-15

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Treatment Center of America Phoenix — Goodyear, Arizona, United States (enrolling)
• The University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
• University of Arkansas at Little Rock — Little Rock, Arkansas, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States (enrolling)
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States (enrolling)
• Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States (enrolling)
• Jupiter Research — Jupiter, Florida, United States (enrolling)
• AdventHealth Medical Group Blood & Marrow Transplant at Orlando — Orlando, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• Memorial Cancer Institute — Pembroke Pines, Florida, United States (enrolling)
• Moffit Cancer center — Tampa, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• University of Chicago Medicine — Chicago, Illinois, United States (enrolling)
• Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• UofL Health Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• Trinity Health Michigan Heart - Ann Arbor Campus — Ypsilanti, Michigan, United States (enrolling)
• Washington University in St Louis — St Louis, Missouri, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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