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NCT06852222PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

6/4/2025

Completion Date

8/15/2029

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Bleximenib

DRUG

Venetoclax (VEN)

DRUG

Azacitidine (AZA)

DRUG

Placebo

Interested in This Trial?

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Conditions

Leukemia, Myeloid, Acute

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Cancer Treatment Center of America Phoenix

Goodyear, Arizona 85338

United States

The University of Arizona Cancer Center

Tucson, Arizona 85724

United States

University of Arkansas at Little Rock

Little Rock, Arkansas 72204

United States

City of Hope

Duarte, California 91010

United States

Rocky Mountain Cancer Centers

Aurora, Colorado 80012

United States

Medical Oncology Hematology Consultants, PA

Newark, Delaware 19713

United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida 33901

United States

Jupiter Research

Jupiter, Florida 33458

United States

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida 32804

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Memorial Cancer Institute

Pembroke Pines, Florida 33026

United States

Moffit Cancer center

Tampa, Florida 33612

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

University of Chicago Medicine

Chicago, Illinois 60637

United States

Illinois Cancer Specialists

Niles, Illinois 60714

United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky 40536

United States

UofL Health Brown Cancer Center

Louisville, Kentucky 40202

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Trinity Health Michigan Heart - Ann Arbor Campus

Ypsilanti, Michigan 48106

United States

Washington University in St Louis

St Louis, Missouri 63130

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

New York Presbyterian - Weill Cornell

New York, New York 10065

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Einstein-Montefiore Medical Center

The Bronx, New York 10467

United States

Atrium Health

Charlotte, North Carolina 28204

United States

Novant Health Charlotte

Charlotte, North Carolina 28204

United States

Carolina Oncology Specialists

Charlotte, North Carolina 28207

United States

Novant Health Winston Salem

Winston-Salem, North Carolina 27106

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

Miami Valley Hospital South

Centerville, Ohio 45459

United States

Oncology Hematology Care

Cincinnati, Ohio 45226

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon 97225

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15260

United States

University of Tennessee

Knoxville, Tennessee 37920

United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee 37232

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - Northeast

Tyler, Texas 75702

United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia 23298

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

Flinders Medical Centre

Bedford Park, 5042

Australia

Royal Prince Alfred Hospital

Camperdown, 2050

Australia

St Vincents Hospital Melbourne

Fitzroy, 3065

Australia

St George Hospital

Kogarah, 2217

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Princess Alexandra Hospital

Woolloongabba, 4102

Australia

Kepler Universitatsklinikum GmbH

Linz, 4020

Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020

Austria

Universitaetsklinikum Salzburg Landeskrankenhaus

Salzburg, 5020

Austria

Medical University of Vienna Universitatsklinik fur Innere Medizin I

Vienna, 1090

Austria

Wiener Gesundheitsverbund Klinik Hietzing

Vienna, 1130

Austria

Klinikum Wels Grieskirchen

Wels, 4600

Austria

AZ Sint-Jan

Bruges, 8000

Belgium

UZ Antwerpen

Edegem, 2650

Belgium

Ziekenhuis Oost-Limburg

Genk, 3600

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Chu Helora Hospital La Louviere Site Jolimont

La Louvière, 7100

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

Clinique Saint Pierre

Ottignies, 1340

Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800

Belgium

Fundacao Pio XII

Barretos, 14780 070

Brazil

DF Star Rede D or

Brasília, 70390 140

Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, 81520 060

Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000

Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, 20230 130

Brazil

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

Rio de Janeiro, 22775 001

Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, 01323 010

Brazil

Instituto D Or de Pesquisa e Ensino

São Paulo, 01401 002

Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652 900

Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Vancouver General Hospital

Vancouver, British Columbia V5Z 1N1

Canada

Cancercare Manitoba

Winnipeg, Manitoba R3E 0V9

Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia B3H 2Y9

Canada

Juravinski Cancer Centre

Hamilton, Ontario L8V 5C2

Canada

London Health Sciences Centre Victoria Hospital

London, Ontario N6A 5W9

Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H1T 2M4

Canada

Peking University First Hospital

Beijing, 100020

China

Peking University People's Hospital

Beijing, 100044

China

Peking University Third Hospital

Beijing, 100191

China

The first Affiliated Hospital of Jilin University

Changchun, 130021

China

Sichuan Provincial Peoples Hospital

Chengdu, 610032

China

West China Hospital Si Chuan University

Chengdu, 610041

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 401147

China

Sun Yat Sen University Cancer Center

Guangzhou, 510060

China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310003

China

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, 230001

China

Qilu Hospital of Shandong University

Jinan, 250012

China

The Second Hospital & Clinical Medical School Lanzhou University

Lanzhou, 730030

China

The First Affiliated Hospital of NanChang University

Nanchang, 330006

China

Zhongda Hospital Southeast University

Nanjing, 210009

China

The First Affiliated Hospital of Guangxi Medical University

Nanning, 530021

China

Shengjing Hospital Of China Medical University

Shenyang, 110055

China

The Second People's Hospital of Shenzhen

Shenzhen, 518035

China

First Affiliated Hospital SooChow University

Suzhou, 215005

China

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

Tijian, 300020

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

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

Wuhan, 430022

China

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

Wuhan, 430030

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004

China

The first affiliated hospital of xiamen university

Xiamen, 361003

China

Henan Cancer Hospital

Zhengzhou, 450008

China

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, 625 00

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, 708 52

Czechia

Fakultni nemocnice Plzen

Pilsen, 304 60

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 00

Czechia

Ustav Hematologie A Krevni Transfuze

Prague, 128 00

Czechia

Vseobecna Fakultní Nemocnice

Prague, 128 08

Czechia

Aalborg University Hospital

Aalborg, 9000

Denmark

Rigshospitalet

Copenhagen, DK 2100

Denmark

Odense University Hospital

Odense, 5000

Denmark

Zealand University Hospital

Roskilde, 4000

Denmark

CHU d'Angers

Angers, 49933

France

CHU de Clermont Ferrand - Site Estaing

Clermont-Ferrand, 63100

France

Hopital Saint Vincent de Paul

Lille, 59020

France

Institut Paoli Calmettes

Marseille, 13273

France

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295

France

CHU De Nice Hopital De l'Archet

Nice, 06202

France

Hopital Saint Louis

Paris, 75010

France

CHU Lyon Sud

Pierre-Bénite, 69310

France

CHU Reims Hopital Robert Debre

Reims, 51100

France

Chu Rennes Hopital Pontchaillou

Rennes, 35000

France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31100

France

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre Ies-Nancy, 54500

France

Institut Gustave Roussy

Villejuif, 94805

France

Klinikum Augsburg

Augsburg, 86156

Germany

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307

Germany

Universitaetsklinikum Frankfurt

Frankfurt, 60590

Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246

Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105

Germany

Universitaetsklinikum Leipzig

Leipzig, 04103

Germany

Klinikum der Universitaet Muenchen

München, 81377

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97080

Germany

University Hospital of Alexandroupolis

Alexandroupoli, 68100

Greece

Evaggelismos Hospital

Athens, 106 76

Greece

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

Chaïdári, 124 62

Greece

University General Hospital of Ioannina

Ioannina, 455 00Q

Greece

General University Hospital of Patras

Rio, 265 04

Greece

Ahepa University General Hospital of Thessaloniki

Thessaloniki, 54636

Greece

Geniko Nosokomeio Thessalonikis George Papanikolaou

Thessaloniki, 570 10

Greece

Queen Mary Hospital

Hong Kong,

Hong Kong

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, 1097

Hungary

Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Győr, 9024

Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7624

Hungary

SZTE Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725

Hungary

Shamir Medical Center Assaf Harofeh

Beer Yaakov, 7033001

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Carmel Medical Center

Haifa, 3436212

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah University Hospita Ein Kerem

Jerusalem, 9112001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Chaim Sheba Medical Center

Ramat Gan, 5262000

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906

Israel

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127

Italy

A O U Sant Orsola Malpighi

Bologna, 40138

Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123

Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014

Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100

Italy

Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

Perugia, 06132

Italy

AST Pesaro e Urbino Ospedale San Salvatore

Pesaro, 61121

Italy

Ospedale S. Maria Delle Croci

Ravenna, 48121

Italy

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

Reggio Calabria, 89124

Italy

IRCCS Istituto Clinico Humanitas

Rozzano, 20089

Italy

Casa Sollievo Della Sofferenza IRCCS

San Giovanni Rotondo, 71013

Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, 10126

Italy

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, 113 8677

Japan

Kyushu University Hospital

Fukuoka, 812 8582

Japan

Fukushima Medical University Hospital

Fukushima, 960 1295

Japan

Gifu Municipal Hospital

Gifu, 500-8513

Japan

Kanazawa University Hospital

Kanazawa, 920-8641

Japan

Kobe City Medical Center General Hospital

Kobe, 650 0047

Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008

Japan

Gunmaken Saiseikai Maebashi Hospital

Maebashi, 371-0821

Japan

Nagoya University Hospital

Nagoya, 466 8560

Japan

Okayama University Hospital

Okayama, 700 8558

Japan

Japanese Red Cross Osaka Hospital

Osaka, 543 8555

Japan

Aiiku Hospital

Sapporo, 064 0804

Japan

Tohoku University Hospital

Sendai, 980 8574

Japan

Nippon Medical School Hospital

Tokyo, 113 8603

Japan

Yamagata University Hospital

Yamagata, 990 2331

Japan

University of Fukui Hospital

Yoshida, 910-1193

Japan

Centro de Investigacion Clinica Chapultepec

Mexico City, 04100

Mexico

Instituto Nacional de Cancerologia

Mexico City, 14080

Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080

Mexico

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15 276

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214

Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, 93 513

Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50 367

Poland

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, 1169 050

Portugal

Uls Santa Maria Hosp. Santa Maria

Lisbon, 1649 028

Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4099 001

Portugal

Instituto Portugues de Oncologia Porto

Porto, 4200 072

Portugal

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319

Portugal

Chungnam National University Hospital

Daejeon, 35015

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 137 701

South Korea

Hosp Univ A Coruna

A Coruña, 15006

Spain

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08041

Spain

Hosp. San Pedro de Alcantara

Cáceres, 10003

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, 08908

Spain

Clinica Univ. de Navarra Madrid

Madrid, 28027

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008

Spain

Hosp. Virgen Del Rocio

Seville, 41013

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833

Taiwan

Chi Mei Medical Center Liouying Branch

Tainan, 736

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Ankara Etlik Sehir Hastanesi

Ankara, 06170

Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Ankara University School of Medicine Cebeci Hospital

Ankara, 06590

Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, 07025

Turkey (Türkiye)

Koc University Medical Faculty

Istanbul, 34010

Turkey (Türkiye)

VM Medical Park Mersin Hospital

Mersin, 33200

Turkey (Türkiye)

Sakarya University Training and Research Hospital

Sakarya, 54100

Turkey (Türkiye)

Ondokuz Mayis University

Samsun, 55139

Turkey (Türkiye)

Royal Sussex County Hospital

Brighton, BN2 5BE

United Kingdom

Addenbrookes Hospital

Cambridge, CB2 0QQ

United Kingdom

Kent and Canterbury Hospital

Canterbury, CT1 3NG

United Kingdom

Colchester Hospital University NHS

Colchester, CO4 5JL

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

The Clatterbridge Cancer Centre

Liverpool, L7 8YA

United Kingdom

Guys' and St Thomas' NHS Trust

London, SE1 9RT

United Kingdom

Derriford Hospital

Plymouth, PL6 8DH

United Kingdom

Worthing Hospital

Worthing, BN11 2DH

United Kingdom