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