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RECRUITING
NCT06852222
PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-06-04

Completion Date

2029-08-15

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Bleximenib

Bleximenib will be administered orally.

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.

Locations (270)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cancer Treatment Center of America Phoenix

Goodyear, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas at Little Rock

Little Rock, Arkansas, United States

City of Hope

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware, United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, United States

Jupiter Research

Jupiter, Florida, United States

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Memorial Cancer Institute

Pembroke Pines, 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

Illinois Cancer Specialists

Niles, Illinois, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

UofL Health Brown Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

MaineHealth Institute for Research

South Portland, Maine, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Trinity Health Michigan Heart - Ann Arbor Campus

Ypsilanti, Michigan, United States

Washington University in St Louis

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Presbyterian - Weill Cornell

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Einstein-Montefiore Medical Center

The Bronx, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Novant Health Charlotte

Charlotte, North Carolina, United States

Carolina Oncology Specialists

Charlotte, North Carolina, United States

Novant Health Winston Salem

Winston-Salem, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Tennessee

Knoxville, Tennessee, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Texas Oncology - Northeast

Tyler, Texas, United States

Intermountain Healthcare LDS Hospital

Salt Lake City, Utah, United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Flinders Medical Centre

Bedford Park, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

St George Hospital

Kogarah, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Kepler Universitatsklinikum GmbH

Linz, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, Austria

Medical University of Vienna Universitatsklinik fur Innere Medizin I

Vienna, Austria

Wiener Gesundheitsverbund Klinik Hietzing

Vienna, Austria

Klinikum Wels Grieskirchen

Wels, Austria

AZ Sint-Jan

Bruges, Belgium

UZ Antwerpen

Edegem, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

Clinique Saint Pierre

Ottignies, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

Fundacao Pio XII

Barretos, Brazil

IDOR - Regional Brasilia

Brasília, Brazil

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

IDOR - Regional Sao Paulo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Cancercare Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre Victoria Hospital

London, Ontario, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

And 170 more locations on ClinicalTrials.gov