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

PHASE3RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

June 4, 2025

Primary Completion Date

June 22, 2029

Study Completion Date

August 15, 2029

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Bleximenib

Bleximenib will be administered orally.

DRUG

Venetoclax (VEN)

VEN will be administered orally.

DRUG

Azacitidine (AZA)

AZA will be administered intravenously or subcutaneously.

DRUG

Placebo

Placebo will be administered orally.

Trial Locations (170)

100

RECRUITING

National Taiwan University Hospital, Taipei

333

RECRUITING

Linkou Chang Gung Memorial Hospital, Taoyuan District

736

RECRUITING

Chi Mei Medical Center Liouying Branch, Tainan City

833

RECRUITING

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

1340

RECRUITING

Clinique Saint Pierre, Ottignies

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2217

RECRUITING

St George Hospital, Kogarah

2650

RECRUITING

UZ Antwerpen, Edegem

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

RECRUITING

Universitair Ziekenhuis Leuven, Leuven

3065

RECRUITING

St Vincents Hospital Melbourne, Fitzroy

3600

RECRUITING

Ziekenhuis Oost-Limburg, Genk

4000

RECRUITING

Zealand University Hospital, Roskilde

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

5000

RECRUITING

Odense University Hospital, Odense

5042

RECRUITING

Flinders Medical Centre, Bedford Park

7100

RECRUITING

Chu Helora Hospital La Louviere Site Jolimont, La Louvière

8000

RECRUITING

AZ Sint-Jan, Bruges

8800

RECRUITING

Algemeen Ziekenhuis Delta, Roeselare

9000

RECRUITING

Ghent University Hospital, Ghent

RECRUITING

Aalborg University Hospital, Aalborg

10003

RECRUITING

Hosp. San Pedro de Alcantara, Cáceres

10408

RECRUITING

National Cancer Center, Goyang-si

13273

RECRUITING

Institut Paoli Calmettes, Marseille

13620

RECRUITING

Seoul National University Bundang Hospital, Gyeonggi-do

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

14642

RECRUITING

University of Rochester Medical Center, Rochester

15006

RECRUITING

Hosp Univ A Coruna, A Coruña

19107

RECRUITING

Thomas Jefferson University, Philadelphia

20162

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

20246

RECRUITING

Universitaetsklinikum Hamburg Eppendorf, Hamburg

24127

RECRUITING

ASST Papa Giovanni XXIII Bergamo, Bergamo

25123

RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

27106

RECRUITING

Novant Health, Winston-Salem

27157

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

28027

RECRUITING

Clinica Univ. de Navarra, Madrid

28034

RECRUITING

Hosp. Univ. Ramon Y Cajal, Madrid

28041

RECRUITING

Hosp. Univ. 12 de Octubre, Madrid

28204

RECRUITING

Atrium Health, Charlotte

RECRUITING

Novant Health, Charlotte

28223

RECRUITING

Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón

31008

RECRUITING

Clinica Univ. de Navarra, Pamplona

31100

RECRUITING

Institut Universitaire du Cancer Toulouse Oncopole, Toulouse

32806

RECRUITING

Orlando Health Cancer Institute, Orlando

33200

RECRUITING

VM Medical Park Mersin Hospital, Mersin

33331

RECRUITING

Cleveland Clinic Florida, Weston

33612

RECRUITING

Moffit Cancer center, Tampa

34010

RECRUITING

Koc University Medical Faculty, Istanbul

35015

RECRUITING

Chungnam National University Hospital, Daejeon

37007

RECRUITING

Hosp Clinico Univ de Salamanca, Salamanca

37920

RECRUITING

University of Tennessee, Knoxville

39008

RECRUITING

Hosp. Univ. Marques de Valdecilla, Santander

40138

RECRUITING

A O U Sant Orsola Malpighi, Bologna

40207

RECRUITING

Norton Cancer Institute, Louisville

41013

RECRUITING

Hosp. Virgen Del Rocio, Seville

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

44195

RECRUITING

Cleveland Clinic, Cleveland

44718

RECRUITING

Gabrail Cancer Center, Canton

47014

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48121

RECRUITING

Ospedale S. Maria Delle Croci, Ravenna

49933

RECRUITING

CHU d'Angers, Angers

51100

RECRUITING

CHU Reims Hopital Robert Debre, Reims

54100

RECRUITING

Sakarya University Training and Research Hospital, Sakarya

54636

RECRUITING

Ahepa University General Hospital of Thessaloniki, Thessaloniki

55139

RECRUITING

Ondokuz Mayis University, Samsun

59020

RECRUITING

Hopital Saint Vincent de Paul, Lille

60590

RECRUITING

Universitaetsklinikum Frankfurt, Frankfurt

63100

RECRUITING

CHU de Clermont Ferrand - Site Estaing, Clermont-Ferrand

63130

RECRUITING

Washington University in St Louis, St Louis

68100

RECRUITING

University Hospital of Alexandroupolis, Alexandroupoli

69120

RECRUITING

Universitaetsklinikum Heidelberg, Heidelberg

69310

RECRUITING

CHU Lyon Sud, Pierre-Bénite

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

71013

RECRUITING

Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo

72204

RECRUITING

University of Arkansas at Little Rock, Little Rock

75010

RECRUITING

Hopital Saint Louis, Paris

75246

RECRUITING

Baylor University Medical Center, Dallas

77030

RECRUITING

MD Anderson Cancer Center, Houston

86156

RECRUITING

Klinikum Augsburg, Augsburg

89124

RECRUITING

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

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Oncology and Hematology Care Clinic Westside, Portland

98104

RECRUITING

Swedish Cancer Institute, Seattle

100020

RECRUITING

Peking University First Hospital, Beijing

100044

RECRUITING

Peking University People s Hospital, Beijing

100191

RECRUITING

Peking University Third Hospital, Beijing

110055

RECRUITING

Shengjing Hospital Of China Medical University, Shenyang

130021

RECRUITING

The first Affiliated Hospital of Jilin University, Changchun

210009

RECRUITING

Zhongda Hospital Southeast University, Nanjing

215005

RECRUITING

First Affiliated Hospital SooChow University, Suzhou

250012

RECRUITING

Qilu Hospital of Shandong University, Jinan

325000

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

330006

RECRUITING

The First Affiliated Hospital of NanChang University, Nanchang

401147

RECRUITING

The First Affiliated Hospital of Chongqing Medical University, Chongqing

430022

RECRUITING

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

510060

RECRUITING

Sun Yat Sen University Cancer Center, Guangzhou

518035

RECRUITING

The Second People's Hospital of Shenzhen, Shenzhen

530021

RECRUITING

The First Affiliated Hospital of Guangxi Medical University, Nanning

610032

RECRUITING

Sichuan Provincial Peoples Hospital, Chengdu

610041

RECRUITING

West China Hospital Si Chuan University, Chengdu

3000200

RECRUITING

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

3109601

RECRUITING

Rambam Medical Center, Haifa

3436212

RECRUITING

Carmel Medical Center, Haifa

4941492

RECRUITING

Rabin Medical Center, Petah Tikva

5262000

RECRUITING

Chaim Sheba Medical Center, Ramat Gan

6423906

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

7033001

RECRUITING

Shamir Medical Center Assaf Harofeh, Beer Yaakov

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

9112001

RECRUITING

Hadassah University Hospita Ein Kerem, Jerusalem

14780 070

RECRUITING

Fundacao Pio XII, Barretos

70390 700

RECRUITING

Instituto D Or de Pesquisa e Ensino, Brasília

81520 060

RECRUITING

Liga Paranaense de Combate ao Cancer, Curitiba

59062 000

RECRUITING

Liga Norte Riograndense Contra O Cancer, Natal

01401 002

RECRUITING

Instituto D Or de Pesquisa e Ensino, São Paulo

05652 900

RECRUITING

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

T2N 5G2

RECRUITING

Arthur J E Child Comprehensive Cancer Centre, Calgary

N6A 5W9

RECRUITING

London Health Sciences Centre Victoria Hospital, London

M5G 1Z5

RECRUITING

Princess Margaret Cancer Centre University Health Network, Toronto

H1T 2M4

RECRUITING

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

625 00

RECRUITING

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Brno

500 05

RECRUITING

Fakultni nemocnice Hradec Kralove, Hradec Králové

708 52

RECRUITING

Fakultni Nemocnice Ostrava, Ostrava - Poruba

304 60

RECRUITING

Fakultni nemocnice Plzen, Pilsen

100 00

RECRUITING

Fakultni nemocnice Kralovske Vinohrady, Prague

128 00

RECRUITING

Ustav Hematologie A Krevni Transfuze, Prague

01307

RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

106 76

RECRUITING

Evaggelismos Hospital, Athens

124 62

RECRUITING

General Hospital of Athens Attikon, Chaïdári

455 00Q

RECRUITING

University General Hospital of Ioannina, Ioannina

265 04

RECRUITING

General University Hospital of Patras, Rio

570 10

RECRUITING

Geniko Nosokomeio Thessalonikis George Papanikolaou, Thessaloniki

113 8677

RECRUITING

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō City

812 8582

RECRUITING

Kyushu University Hospital, Fukuoka

960 1295

RECRUITING

Fukushima Medical University Hospital, Fukushima

500-8513

RECRUITING

Gifu Municipal Hospital, Gifu

650 0047

RECRUITING

Kobe City Medical Center General Hospital, Kobe

860-0008

RECRUITING

National Hospital Organization Kumamoto Medical Center, Kumamoto

371-0821

RECRUITING

Gunmaken Saiseikai Maebashi Hospital, Maebashi

466 8560

RECRUITING

Nagoya University Hospital, Nagoya

700 8558

RECRUITING

Okayama University Hospital, Okayama

543 8555

RECRUITING

Japanese Red Cross Osaka Hospital, Osaka

064 0804

RECRUITING

Aiiku Hospital, Sapporo

980 8574

RECRUITING

Tohoku University Hospital, Sendai

113 8603

RECRUITING

Nippon Medical School Hospital, Tokyo

990 2331

RECRUITING

Yamagata University Hospital, Yamagata

910-1193

RECRUITING

University of Fukui Hospital, Yoshida

80 211

RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

25 734

RECRUITING

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce

93 513

RECRUITING

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz

50 367

RECRUITING

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

1169 050

RECRUITING

Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos, Lisbon

4099 001

RECRUITING

Uls Santo Antonio - Hosp. Santo Antonio, Porto

4200 072

RECRUITING

Instituto Portugues de Oncologia, Porto

4200 319

RECRUITING

Uls Sao Joao - Hosp. Sao Joao, Porto

03080

RECRUITING

Seoul National University Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

137 701

RECRUITING

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08035

RECRUITING

Hosp Univ Vall D Hebron, Barcelona

06170

RECRUITING

Ankara Etlik Sehir Hastanesi, Ankara

06200

RECRUITING

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara

06590

RECRUITING

Ankara University School of Medicine Cebeci Hospital, Ankara

07025

RECRUITING

Memorial Antalya Hospital, Antalya

BN2 5BE

RECRUITING

University Hospitals Sussex NHS Foundation Trust, Brighton

CB2 0QQ

RECRUITING

Addenbrookes Hospital, Cambridge

CT1 3NG

RECRUITING

Kent and Canterbury Hospital, Canterbury

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh

L7 8YA

RECRUITING

The Clatterbridge Cancer Centre, Liverpool

PL6 8DH

RECRUITING

Derriford Hospital, Plymouth

BN11 2DH

RECRUITING

University Hospitals Sussex NHS Foundation Trust, Worthing

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY