RecruitingPhase 3NCT06852222

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


Sponsor

Janssen Research & Development, LLC

Enrollment

600 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — bleximenib, venetoclax, and azacitidine — for people newly diagnosed with a type of blood cancer called acute myeloid leukemia (AML) who are not healthy enough to receive intensive chemotherapy. **You may be eligible if:** - You are 18 years or older - You have been newly diagnosed with AML with specific genetic features (KMT2A rearrangement or NPM1 mutation) - You are not a candidate for intensive chemotherapy due to age (75+) or health conditions such as heart problems, lung problems, kidney problems, or other serious health issues - You have adequate liver and kidney function - You are willing to use effective contraception during and after treatment **You may NOT be eligible if:** - You have a specific type of leukemia called acute promyelocytic leukemia (APL) - The cancer has spread to your brain or spinal fluid - You have had a solid organ transplant - You had a heart attack, stroke, or serious heart problem within the last 6 months - You have active hepatitis B or C infection - You have received a live vaccine recently - You have known allergies to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBleximenib

Bleximenib will be administered orally.

DRUGVenetoclax (VEN)

VEN will be administered orally.

DRUGAzacitidine (AZA)

AZA will be administered intravenously or subcutaneously.

DRUGPlacebo

Placebo will be administered orally.


Locations(239)

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

Jupiter Research

Jupiter, Florida, United States

Orlando Health Cancer Institute

Orlando, 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

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

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, 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

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

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

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

MD Anderson Cancer Center

Houston, Texas, 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

DF Star Rede D or

Brasília, Brazil

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

Instituto D Or de Pesquisa e Ensino

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

Peking University Third Hospital

Beijing, China

The first Affiliated Hospital of Jilin University

Changchun, China

Sichuan Provincial Peoples Hospital

Chengdu, China

West China Hospital Si Chuan University

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Sun Yat Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, China

Qilu Hospital of Shandong University

Jinan, China

The Second Hospital & Clinical Medical School Lanzhou University

Lanzhou, China

The First Affiliated Hospital of NanChang University

Nanchang, China

Zhongda Hospital Southeast University

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Shengjing Hospital Of China Medical University

Shenyang, China

The Second People's Hospital of Shenzhen

Shenzhen, China

First Affiliated Hospital SooChow University

Suzhou, China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tijian, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The first affiliated hospital of xiamen university

Xiamen, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni nemocnice Plzen

Pilsen, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Ustav Hematologie A Krevni Transfuze

Prague, Czechia

Vseobecna Fakultní Nemocnice

Prague, Czechia

Aalborg University Hospital

Aalborg, Denmark

Odense University Hospital

Odense, Denmark

Zealand University Hospital

Roskilde, Denmark

CHU d'Angers

Angers, France

CHU de Clermont Ferrand - Site Estaing

Clermont-Ferrand, France

Hopital Saint Vincent de Paul

Lille, France

Institut Paoli Calmettes

Marseille, France

CHU de Montpellier Hopital Saint Eloi

Montpellier, France

CHU De Nice Hopital De l'Archet

Nice, France

Hopital Saint Louis

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

CHU Reims Hopital Robert Debre

Reims, France

Chu Rennes Hopital Pontchaillou

Rennes, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre Ies-Nancy, France

Institut Gustave Roussy

Villejuif, France

Klinikum Augsburg

Augsburg, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Universitaetsklinikum Frankfurt

Frankfurt, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

Evaggelismos Hospital

Athens, Greece

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Chaïdári, Greece

University General Hospital of Ioannina

Ioannina, Greece

General University Hospital of Patras

Rio, Greece

Ahepa University General Hospital of Thessaloniki

Thessaloniki, Greece

Geniko Nosokomeio Thessalonikis George Papanikolaou

Thessaloniki, Greece

Queen Mary Hospital

Hong Kong, Hong Kong

Shamir Medical Center Assaf Harofeh

Beer Yaakov, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah University Hospita Ein Kerem

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

ASST Papa Giovanni XXIII Bergamo

Bergamo, Italy

A O U Sant Orsola Malpighi

Bologna, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

Perugia, Italy

AST Pesaro e Urbino Ospedale San Salvatore

Pesaro, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

Reggio Calabria, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Gifu Municipal Hospital

Gifu, Japan

Kanazawa University Hospital

Kanazawa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Gunmaken Saiseikai Maebashi Hospital

Maebashi, Japan

Nagoya University Hospital

Nagoya, Japan

Okayama University Hospital

Okayama, Japan

Japanese Red Cross Osaka Hospital

Osaka, Japan

Aiiku Hospital

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Nippon Medical School Hospital

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

University of Fukui Hospital

Yoshida, Japan

Centro de Investigacion Clinica Chapultepec

Mexico City, Mexico

Instituto Nacional de Cancerologia

Mexico City, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Poland

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, Portugal

Uls Santa Maria Hosp. Santa Maria

Lisbon, Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, Portugal

Instituto Portugues de Oncologia Porto

Porto, Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, Portugal

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp Univ A Coruna

A Coruña, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Clinic de Barcelona

Barcelona, Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp. San Pedro de Alcantara

Cáceres, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, Spain

Clinica Univ. de Navarra Madrid

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Chi Mei Medical Center Liouying Branch

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Ankara Etlik Sehir Hastanesi

Ankara, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Ankara University School of Medicine Cebeci Hospital

Ankara, Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, Turkey (Türkiye)

Koc University Medical Faculty

Istanbul, Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mersin, Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, Turkey (Türkiye)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Royal Sussex County Hospital

Brighton, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

Colchester Hospital University NHS

Colchester, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

Guys' and St Thomas' NHS Trust

London, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Worthing Hospital

Worthing, United Kingdom

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NCT06852222


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