Recruiting
Phase 3

Bleximenib & VEN+AZA

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06852222

Conditions

Leukemia, Myeloid, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bleximenib

Venetoclax (VEN)

Azacitidine (AZA)

Placebo

Study Details

Brief 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.

Conditions

Leukemia, Myeloid, Acute

Study ID

NCT06852222

Start date

Jun 4, 2025

Status verified date

Aug, 2026

Completion date

Aug 15, 2029

Anticipated

Primary completion date

Jun 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Bleximenib and Venetoclax (VEN) + Azacitidine (AZA)

Participants with acute myeloid leukemia (AML) will receive bleximenib in combination with venetoclax (VEN) and azacitidine (AZA) for 28-days treatment cycles and treatment will continue until progression or unacceptable toxicity.

placebo comparator: Arm B: Placebo and Venetoclax (VEN) + Azacitidine (AZA)

Participants with AML will receive placebo in combination with VEN and AZA for 28-days treatment cycles, and treatment will continue until progression or unacceptable toxicity.

Interventions

Bleximenib

Bleximenib will be administered orally.

Venetoclax (VEN)

VEN will be administered orally.

Azacitidine (AZA)

AZA will be administered intravenously or subcutaneously.

Placebo

Placebo will be administered orally.

Primary outcome measure

  • Percentage of Participants who Achieve Complete Remission (CR) [ Time Frame: Up to 4 years and 1 month ]
  • Overall Survival (OS) [ Time Frame: Up to 4 years and 1 month ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Cancer Treatment Center of America Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

The University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

University of Arkansas at Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

City of Hope

Recruiting

Duarte, California, United States, 91010

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Medical Oncology Hematology Consultants, PA

Recruiting

Newark, Delaware, United States, 19713

Florida Cancer Specialists & Research Institute

Recruiting

Fort Myers, Florida, United States, 33901

Jupiter Research

Recruiting

Jupiter, Florida, United States, 33458

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Recruiting

Orlando, Florida, United States, 32804

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Memorial Cancer Institute

Recruiting

Pembroke Pines, Florida, United States, 33026

Moffit Cancer center

Recruiting

Tampa, Florida, United States, 33612

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

University of Kentucky Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

UofL Health Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Center for Cancer and Blood Disorders

Recruiting

Bethesda, Maryland, United States, 20817

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Trinity Health Michigan Heart - Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48106

Washington University in St Louis

Recruiting

St Louis, Missouri, United States, 63130

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

New York Presbyterian - Weill Cornell

Recruiting

New York, New York, United States, 10065

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Einstein-Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Charlotte

Recruiting

Charlotte, North Carolina, United States, 28204

Carolina Oncology Specialists

Recruiting

Charlotte, North Carolina, United States, 28207

Novant Health Winston Salem

Recruiting

Winston-Salem, North Carolina, United States, 27106

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45226

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Providence Oncology and Hematology Care Clinic Westside

Recruiting

Portland, Oregon, United States, 97225

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

University of Tennessee

Recruiting

Knoxville, Tennessee, United States, 37920

Vanderbilt Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Houston Methodist Cancer Center

Recruiting

Houston, Texas, United States, 77030

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Northeast

Recruiting

Tyler, Texas, United States, 75702

Intermountain Healthcare LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Virginia Commonwealth University - Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1N1

Cancercare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

London Health Sciences Centre Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Princess Margaret Cancer Centre University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.