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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Bleximenib
    Bleximenib will be administered orally.
    Other names:
    • JNJ-75276617
  • Drug: Venetoclax (VEN)
    VEN will be administered orally.
  • Drug: Azacitidine (AZA)
    AZA will be administered intravenously or subcutaneously.
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.
  • Drug: Venetoclax (VEN)
    VEN will be administered orally.
  • Drug: Azacitidine (AZA)
    AZA will be administered intravenously or subcutaneously.
  • Drug: Placebo
    Placebo will be administered orally.

Recruiting Locations

Cancer Treatment Center of America Phoenix
Goodyear, Arizona 85338

University of Arkansas at Little Rock
Little Rock, Arkansas 72204

City of Hope
Duarte, California 91010

Jupiter Research
Jupiter, Florida 33458

Orlando Health Cancer Institute
Orlando, Florida 32806

Moffit Cancer center
Tampa, Florida 33612

Cleveland Clinic Florida
Weston, Florida 33331

University of Chicago Medicine
Chicago, Illinois 60637

University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536

UofL Health Brown Cancer Center
Louisville, Kentucky 40202

Norton Cancer Institute
Louisville, Kentucky 40207

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809

Dana Farber Cancer Institute
Boston, Massachusetts 02115

Henry Ford Health System
Detroit, Michigan 48202

Washington University in St Louis
St Louis, Missouri 63130

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263

New York Presbyterian - Weill Cornell
New York, New York 10065

University of Rochester Medical Center
Rochester, New York 14642

Einstein-Montefiore Medical Center
The Bronx, New York 10467

Atrium Health
Charlotte, North Carolina 28204

Novant Health Charlotte
Charlotte, North Carolina 28204

Novant Health Winston Salem
Winston-Salem, North Carolina 27106

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

Gabrail Cancer Center
Canton, Ohio 44718

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Cleveland Clinic
Cleveland, Ohio 44195

Providence Portland Medical Center
Portland, Oregon 97213

Providence Oncology and Hematology Care Clinic Westside
Portland, Oregon 97225

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15260

University of Tennessee
Knoxville, Tennessee 37920

Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232

Baylor University Medical Center
Dallas, Texas 75246

MD Anderson Cancer Center
Houston, Texas 77030

Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia 23298

Swedish Cancer Institute
Seattle, Washington 98104

Fred Hutchinson Cancer Center
Seattle, Washington 98109

More Details

NCT ID
NCT06852222
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.