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A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
Sponsor: Janssen Research & Development, LLC
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
Conditions
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.
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