A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Myeloid, Acute
• Intervention / Treatment: Drug: Placebo; Drug: Bleximenib; Drug: Venetoclax (VEN); Drug: Azacitidine (AZA)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • Bedford Park, Australia, 5042
    • Recruiting
    • Flinders Medical Centre
  • Camperdown, Australia, 2050
    • Recruiting
    • Royal Prince Alfred Hospital
  • Fitzroy, Australia, 3065
    • Recruiting
    • St Vincents Hospital Melbourne
  • Kogarah, Australia, 2217
    • Recruiting
    • St George Hospital
  • Melbourne, Australia, 3000
    • Recruiting
    • Peter MacCallum Cancer Centre
  • Woolloongabba, Australia, 4102
    • Recruiting
    • Princess Alexandra Hospital
• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
  • Linz, Austria, 4020
    • Recruiting
    • Kepler Universitätsklinikum GmbH
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitaetsklinikum Salzburg Landeskrankenhaus
  • Vienna, Austria, 1130
    • Recruiting
    • Wiener Gesundheitsverbund Klinik Hietzing
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna Universitatsklinik fur Innere Medizin I
  • Wels, Austria, 4600
    • Recruiting
    • Klinikum Wels Grieskirchen
• Belgium
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
  • La Louvière, Belgium, 7100
    • Recruiting
    • Chu Helora Hospital La Louviere Site Jolimont
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
  • Ottignies, Belgium, 1340
    • Recruiting
    • Clinique Saint Pierre
  • Roeselare, Belgium, 8800
    • Recruiting
    • Algemeen Ziekenhuis Delta
• Brazil
  • Barretos, Brazil, 14780 070
    • Recruiting
    • Fundação Pio XII
  • Brasília, Brazil, 70390 140
    • Recruiting
    • DF Star Rede D or
  • Curitiba, Brazil, 81520 060
    • Recruiting
    • Liga Paranaense de Combate ao Cancer
  • Natal, Brazil, 59062 000
    • Recruiting
    • Liga Norte Riograndense Contra O Cancer
  • Rio de Janeiro, Brazil, 22775 001
    • Recruiting
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Rio de Janeiro, Brazil, 20230 130
    • Recruiting
    • Ministerio da Saude Instituto Nacional do Cancer
  • São Paulo, Brazil, 01401 002
    • Recruiting
    • Instituto D Or de Pesquisa e Ensino
  • São Paulo, Brazil, 05652 900
    • Recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01323 010
    • Recruiting
    • Real e Benemerita Associacao Portuguesa de Beneficencia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur J E Child Comprehensive Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1N1
      • Recruiting
      • Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Recruiting
      • CancerCare Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Recruiting
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre Victoria Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China, 100020
    • Recruiting
    • Peking University First Hospital
  • Changchun, China, 130021
    • Recruiting
    • The First Affiliated Hospital of Jilin University
  • Chengdu, China, 610032
    • Recruiting
    • Sichuan Provincial Peoples Hospital
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital Si Chuan University
  • Chongqing, China, 401147
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
  • Guangzhou, China, 510060
    • Recruiting
    • Sun Yat Sen University Cancer Center
  • Hangzhou, China, 310003
    • Recruiting
    • The First Affiliated Hospital Zhejiang University College of Medicine
  • Hefei, China, 230001
    • Recruiting
    • The First Affiliated Hospital of USTC Anhui Provincial Hospital
  • Jinan, China, 250012
    • Recruiting
    • Qilu Hospital of Shandong University
  • Lanzhou, China, 730030
    • Recruiting
    • The Second Hospital & Clinical Medical School Lanzhou University
  • Nanchang, China, 330006
    • Recruiting
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210009
    • Recruiting
    • Zhongda Hospital Southeast University
  • Nanning, China, 530021
    • Recruiting
    • The First Affiliated Hospital of Guangxi Medical University
  • Shenyang, China, 110055
    • Recruiting
    • Shengjing Hospital Of China Medical University
  • Shenzhen, China, 518035
    • Recruiting
    • The Second People's Hospital of Shenzhen
  • Suzhou, China, 215005
    • Recruiting
    • First Affiliated Hospital SooChow University
  • Tijian, China, 3000200
    • Recruiting
    • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • Wenzhou, China, 325000
    • Recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430030
    • Recruiting
    • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
  • Wuhan, China, 430022
    • Recruiting
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'an, China, 710004
    • Recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China, 361003
    • Recruiting
    • The First Affiliated Hospital of Xiamen University
  • Zhengzhou, China, 450008
    • Recruiting
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultní nemocnice Brno, Interní hematologická a onkologická klinika
  • Hradec Králové, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Ostrava - Poruba, Czechia, 708 52
    • Recruiting
    • Fakultni Nemocnice Ostrava
  • Pilsen, Czechia, 304 60
    • Recruiting
    • Fakultni Nemocnice Plzen
  • Prague, Czechia, 128 08
    • Recruiting
    • Vseobecna Fakultni Nemocnice
  • Prague, Czechia, 100 00
    • Recruiting
    • Fakultní nemocnice Královské Vinohrady
  • Prague, Czechia, 128 00
    • Recruiting
    • Ustav hematologie a krevni transfuze
• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
  • Copenhagen, Denmark, DK 2100
    • Recruiting
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Recruiting
    • Zealand University Hospital
• France
  • Angers, France, 49933
    • Recruiting
    • CHU d'Angers
  • Clermont-Ferrand, France, 63100
    • Recruiting
    • CHU de Clermont Ferrand - Site Estaing
  • Lille, France, 59020
    • Recruiting
    • Hôpital Saint Vincent de Paul
  • Marseille, France, 13273
    • Recruiting
    • Institut Paoli Calmettes
  • Montpellier, France, 34295
    • Recruiting
    • CHU de Montpellier Hopital Saint Eloi
  • Nice, France, 06202
    • Recruiting
    • Chu de Nice Hopital de L'Archet
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint Louis
  • Pierre-Bénite, France, 69310
    • Recruiting
    • CHU Lyon Sud
  • Reims, France, 51100
    • Recruiting
    • CHU Reims Hopital Robert Debre
  • Rennes, France, 35000
    • Recruiting
    • Chu Rennes Hopital Pontchaillou
  • Toulouse, France, 31100
    • Recruiting
    • Institut Universitaire du Cancer Toulouse Oncopole
  • Vandœuvre Ies-Nancy, France, 54500
    • Recruiting
    • CHRU de Nancy - Hôpitaux de Brabois
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • Klinikum Augsburg
  • Cologne, Germany, 50937
    • Recruiting
    • Universitaetsklinikum Koeln
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Frankfurt, Germany, 60590
    • Recruiting
    • Universitaetsklinikum Frankfurt
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitaetsklinikum Freiburg
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitaetsklinikum Hamburg Eppendorf
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitaetsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Recruiting
    • Universitaetsklinikum Schleswig Holstein Campus Kiel
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Universitaet Muenchen
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitaetsklinikum Wuerzburg
• Greece
  • Alexandroupoli, Greece, 68100
    • Recruiting
    • University Hospital of Alexandroupolis
  • Athens, Greece, 106 76
    • Recruiting
    • Evaggelismos Hospital
  • Chaïdári, Greece, 124 62
    • Recruiting
    • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
  • Ioannina, Greece, 455 00Q
    • Recruiting
    • University General Hospital of Ioannina
  • Rio, Greece, 265 04
    • Recruiting
    • General University Hospital of Patras
  • Thessaloniki, Greece, 54636
    • Recruiting
    • AHEPA University General Hospital of Thessaloniki
  • Thessaloniki, Greece, 570 10
    • Recruiting
    • Geniko Nosokomeio Thessalonikis George Papanikolaou
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
• Israel
  • Beer Yaakov, Israel, 7033001
    • Recruiting
    • Shamir Medical Center Assaf Harofeh
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah University Hospita Ein Kerem
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • Asst Papa Giovanni Xxiii Bergamo
  • Bologna, Italy, 40138
    • Recruiting
    • A O U Sant Orsola Malpighi
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Meldola, Italy, 47014
    • Recruiting
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20162
    • Recruiting
    • Asst Grande Ospedale Metropolitano Niguarda
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
  • Perugia, Italy, 06132
    • Recruiting
    • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
  • Pesaro, Italy, 61121
    • Recruiting
    • AST Pesaro e Urbino Ospedale San Salvatore
  • Ravenna, Italy, 48121
    • Recruiting
    • Ospedale S. Maria Delle Croci
  • Reggio Calabria, Italy, 89124
    • Recruiting
    • Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
  • Rozzano, Italy, 20089
    • Recruiting
    • IRCCS Istituto Clinico Humanitas
  • San Giovanni Rotondo, Italy, 71013
    • Recruiting
    • Casa Sollievo Della Sofferenza IRCCS
  • Torino, Italy, 10126
    • Recruiting
    • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
• Japan
  • Bunkyō City, Japan, 113 8677
    • Recruiting
    • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • Fukuoka, Japan, 812 8582
    • Recruiting
    • Kyushu University Hospital
  • Fukushima, Japan, 960 1295
    • Recruiting
    • Fukushima Medical University Hospital
  • Gifu, Japan, 500-8513
    • Recruiting
    • Gifu Municipal Hospital
  • Kanazawa, Japan, 920-8641
    • Recruiting
    • Kanazawa University Hospital
  • Kobe, Japan, 650 0047
    • Recruiting
    • Kobe City Medical Center General Hospital
  • Kumamoto, Japan, 860-0008
    • Recruiting
    • National Hospital Organization Kumamoto Medical Center
  • Maebashi, Japan, 371-0821
    • Recruiting
    • Gunmaken Saiseikai Maebashi Hospital
  • Nagoya, Japan, 466 8560
    • Recruiting
    • Nagoya University Hospital
  • Okayama, Japan, 700 8558
    • Recruiting
    • Okayama University Hospital
  • Osaka, Japan, 543 8555
    • Recruiting
    • Japanese Red Cross Osaka Hospital
  • Sapporo, Japan, 064 0804
    • Recruiting
    • Aiiku Hospital
  • Sendai, Japan, 980 8574
    • Recruiting
    • Tohoku University Hospital
  • Tokyo, Japan, 113 8603
    • Recruiting
    • Nippon Medical School Hospital
  • Yamagata, Japan, 990 2331
    • Recruiting
    • Yamagata University Hospital
  • Yoshida, Japan, 910-1193
    • Recruiting
    • University of Fukui Hospital
• Mexico
  • Mexico City, Mexico, 14080
    • Recruiting
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Mexico City, Mexico, 14080
    • Recruiting
    • Instituto Nacional De Cancerologia
  • Mexico City, Mexico, 04100
    • Recruiting
    • Centro de Investigacion Clinica Chapultepec
• Poland
  • Bialystok, Poland, 15 276
    • Recruiting
    • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • Gdansk, Poland, 80 214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Kielce, Poland, 25 734
    • Recruiting
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Lodz, Poland, 93 513
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
  • Wroclaw, Poland, 50 367
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• Portugal
  • Lisbon, Portugal, 1169 050
    • Recruiting
    • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
  • Lisbon, Portugal, 1649 028
    • Recruiting
    • Uls Santa Maria Hosp. Santa Maria
  • Porto, Portugal, 4200 319
    • Recruiting
    • Uls Sao Joao - Hosp. Sao Joao
  • Porto, Portugal, 4099 001
    • Recruiting
    • Uls Santo Antonio - Hosp. Santo Antonio
  • Porto, Portugal, 4200 072
    • Recruiting
    • Instituto Portugues de Oncologia Porto
• South Korea
  • Daejeon, South Korea, 35015
    • Recruiting
    • Chungnam National University Hospital
  • Goyang-si, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Gyeonggi-do, South Korea, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 137 701
    • Recruiting
    • The Catholic University of Korea Seoul St Marys Hospital
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Hosp Univ A Coruna
  • Barcelona, Spain, 08041
    • Recruiting
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp. Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Cáceres, Spain, 10003
    • Recruiting
    • Hosp. San Pedro de Alcantara
  • Jerez de la Frontera, Spain, 11407
    • Recruiting
    • Hosp. de Jerez de La Frontera
  • L'Hospitalet de Llobregat, Spain, 08908
    • Recruiting
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Madrid, Spain, 28034
    • Recruiting
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Univ. de Navarra Madrid
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Univ. de Navarra
  • Pozuelo de Alarcón, Spain, 28223
    • Recruiting
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Recruiting
    • Hosp Clinico Univ de Salamanca
  • Santander, Spain, 39008
    • Recruiting
    • Hosp. Univ. Marques de Valdecilla
  • Seville, Spain, 41013
    • Recruiting
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46026
    • Recruiting
    • Hosp. Univ. I Politecni La Fe
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
  • Tainan, Taiwan, 736
    • Recruiting
    • Chi Mei Medical Center Liouying Branch
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Linkou Chang Gung Memorial Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06200
    • Recruiting
    • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06170
    • Recruiting
    • Ankara Etlik Şehir Hastanesi
  • Ankara, Turkey (Türkiye), 06590
    • Recruiting
    • Ankara University School of Medicine Cebeci Hospital
  • Antalya, Turkey (Türkiye), 07025
    • Recruiting
    • Memorial Antalya Hospital
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Koc University Medical Faculty
  • Mersin, Turkey (Türkiye), 33200
    • Recruiting
    • VM Medical Park Mersin Hospital
  • Sakarya, Turkey (Türkiye), 54100
    • Recruiting
    • Sakarya University Training and Research Hospital
  • Samsun, Turkey (Türkiye), 55139
    • Recruiting
    • Ondokuz Mayis University
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Recruiting
    • Royal Sussex County Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Addenbrookes Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Recruiting
    • Kent and Canterbury Hospital
  • Colchester, United Kingdom, CO4 5JL
    • Recruiting
    • Colchester Hospital University NHS
  • Edinburgh, United Kingdom, EH4 2XU
    • Recruiting
    • Western General Hospital
  • Liverpool, United Kingdom, L7 8YA
    • Recruiting
    • The Clatterbridge Cancer Centre
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guys' and St Thomas' NHS Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • Derriford Hospital
  • Worthing, United Kingdom, BN11 2DH
    • Recruiting
    • Worthing Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Recruiting
      • Cancer Treatment Center of America Phoenix
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • The University of Arizona Cancer Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Recruiting
      • University of Arkansas at Little Rock
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Medical Oncology Hematology Consultants, PA
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Florida Cancer Specialists & Research Institute
    • Jupiter, Florida, United States, 33458
      • Recruiting
      • Jupiter Research
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Cancer Institute
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffit Cancer Center
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine
    • Niles, Illinois, United States, 60714
      • Recruiting
      • Illinois Cancer Specialists
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Markey Cancer Center
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • UofL Health Brown Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Recruiting
      • Mary Bird Perkins Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
    • Ypsilanti, Michigan, United States, 48106
      • Recruiting
      • Trinity Health Michigan Heart - Ann Arbor Campus
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University in St Louis
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center at Hackensack University Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian - Weill Cornell
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Einstein-Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Atrium Health
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Oncology Specialists of Charlotte
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Novant Health Charlotte
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    • Winston-Salem, North Carolina, United States, 27106
      • Recruiting
      • Novant Health Winston Salem
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Oncology and Hematology Care Clinic Westside
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt Ingram Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University - Massey Cancer Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Placebo will be administered orally.; Drug: Venetoclax (VEN); VEN will be administered orally.; Drug: Azacitidine (AZA); AZA will be administered intravenously or subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival time is defined as the time duration from the date of randomization to death due to any cause.	Up to 4 years and 1 month
Percentage of Participants who Achieve Complete Remission (CR)	CR is defined as Bone marrow blasts less than (<) 5 percent (%); Absence of circulating blasts; Absence of extramedullary disease; Absolute neutrophil count (ANC) greater than or equal to (>=) 1.0 * 10^9/Liter (1,000/microliter [mcL]); Platelet count >= 100 * 10^9/L (100,000/mcL).	Up to 4 years and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS)	EFS is defined as the time from randomization to treatment failure, relapse, or death due to any cause, whichever occurs first.	Up to 4 years and 1 month
Duration of CR	Duration of CR will be estimated among responders from the date of initial documentation of CR, to the date of first documented evidence of relapse, or death due to any cause, whichever occurs first, respectively.	Up to 4 years and 1 month
Time to CR	Time to CR is defined as time from randomization to first documented response.	Up to 4 years and 1 month
Percentage of Participants who Achieved Transfusion Independence	Transfusion independence is defined as lack of requirement for red blood cell (RBC) and platelet transfusions during any 56-day period.	Up to 4 years and 1 month
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 4 years and 1 month
Number of Participants with Abnormalities in Clinical Laboratory Parameters	Participants with abnormalities in clinical laboratory parameters will be reported.	Up to 4 years and 1 month
Serum Concentration of Bleximenib	Serum samples will be analyzed to determine concentrations of bleximenib.	Up to 4 years and 1 month
Rate of CR Without Measurable Residual Disease (MRD-)	Rate of CR MRD- is defined as percentage of participants who have achieved CR without MRD.	Up to 4 years and 1 month
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)	Allo-HSCT rate is defined as the percentage of participants who have undergone allo-HSCT after randomization.	Up to 4 years and 1 month

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2025
• Primary Completion (Estimated): June 22, 2029
• Study Completion (Estimated): August 15, 2029

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Azacitidine; venetoclax
• Other Study ID Numbers: 75276617AML3001 (Other Identifier: Janssen Research & Development, LLC); 2024-520154-38-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No