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

RECRUITINGPHASE3

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

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

NCT06852222•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (238)

Cancer Treatment Center of America Phoenix

Goodyear, Arizona, United States

University of Arkansas at Little Rock

Little Rock, Arkansas, United States

City of Hope

Duarte, California, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Jupiter Research

Jupiter, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Moffit Cancer center

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

University of Chicago Medicine

Chicago, Illinois, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Key Dates

Start Date

June 4, 2025

Primary Completion Date

June 22, 2029

Completion Date

August 15, 2029

Last Updated

March 19, 2026

Enrollment

600

ESTIMATED participants

Conditions

Leukemia, Myeloid, Acute

Interventions

Bleximenib

DRUG

Venetoclax (VEN)

DRUG

Azacitidine (AZA)

DRUG

Placebo

DRUG

Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

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