NCT06852222From ClinicalTrials.govRecruiting

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

Leukemia, Myeloid, Acute

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 600
Started: 4 June 2025
Main results due: 22 June 2029
Study sites: 266
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(266)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, United States
Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
University of Arkansas at Little Rock
Little Rock, Arkansas, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Recruiting
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Recruiting
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Recruiting
Jupiter Research
Jupiter, Florida, United States
Recruiting
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Recruiting
Moffit Cancer center
Tampa, Florida, United States
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Recruiting
University of Chicago Medicine
Chicago, Illinois, United States
Recruiting
Illinois Cancer Specialists
Niles, Illinois, United States
Recruiting
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
UofL Health Brown Cancer Center
Louisville, Kentucky, United States
Recruiting
Norton Cancer Institute
Louisville, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Recruiting
Henry Ford Health System
Detroit, Michigan, United States
Recruiting
Trinity Health Michigan Heart - Ann Arbor Campus
Ypsilanti, Michigan, United States
Recruiting
Washington University in St Louis
St Louis, Missouri, United States
Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
New York Presbyterian - Weill Cornell
New York, New York, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
Einstein-Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Atrium Health
Charlotte, North Carolina, United States
Recruiting
Novant Health Charlotte
Charlotte, North Carolina, United States
Recruiting
Carolina Oncology Specialists
Charlotte, North Carolina, United States
Recruiting
Novant Health Winston Salem
Winston-Salem, North Carolina, United States
Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Recruiting
Gabrail Cancer Center
Canton, Ohio, United States
Recruiting
Miami Valley Hospital South
Centerville, Ohio, United States
Recruiting
Oncology Hematology Care
Cincinnati, Ohio, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Providence Portland Medical Center
Portland, Oregon, United States
Recruiting
Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon, United States
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Recruiting
University of Tennessee
Knoxville, Tennessee, United States
Recruiting
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Recruiting
Baylor University Medical Center
Dallas, Texas, United States
Recruiting
Houston Methodist Cancer Center
Houston, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Recruiting
Texas Oncology - Northeast
Tyler, Texas, United States
Recruiting
Intermountain Healthcare LDS Hospital
Salt Lake City, Utah, United States
Recruiting
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States
Recruiting
Swedish Cancer Institute
Seattle, Washington, United States
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
Flinders Medical Centre
Bedford Park, Australia
Recruiting

Showing 60 of 266 sites — filter to narrow it down. 266 of the 266 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06852222. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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