A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT ID: NCT06852222
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-06-04
2029-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Bleximenib
Bleximenib will be administered orally.
Venetoclax (VEN)
VEN will be administered orally.
Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
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.
Venetoclax (VEN)
VEN will be administered orally.
Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
Placebo
Placebo will be administered orally.
Interventions
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Bleximenib
Bleximenib will be administered orally.
Venetoclax (VEN)
VEN will be administered orally.
Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
Placebo
Placebo will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Arkansas at Little Rock
Little Rock, Arkansas, United States
City of Hope
Duarte, California, 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 Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Washington University in St Louis
St Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Novant Health
Charlotte, North Carolina, United States
Novant Health
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 Tennessee
Knoxville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, 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
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
Instituto D Or de Pesquisa e Ensino
Brasília, , Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Liga Norte Riograndense Contra O Cancer
Natal, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, , 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
Cancercare Manitoba
Winnipeg, Manitoba, 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
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , 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 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
Klinikum Augsburg
Augsburg, , Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Universitaetsklinikum Frankfurt
Frankfurt, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Evaggelismos Hospital
Athens, , Greece
General Hospital of Athens Attikon
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
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
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
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
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 Santo Antonio - Hosp. Santo Antonio
Porto, , Portugal
Instituto Portugues de Oncologia
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
Clinica Univ. de Navarra
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 District, , 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)
University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
The Clatterbridge Cancer Centre
Liverpool, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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75276617AML3001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-520154-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
75276617AML3001
Identifier Type: -
Identifier Source: org_study_id