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

NCT06852222 · Janssen Research & Development, LLC
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Official title
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
About this study
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
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 design
Enrollment target: 600 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-04
Estimated completion: 2029-08-15
Last updated: 2026-04-13
Interventions
Drug: BleximenibDrug: Venetoclax (VEN)Drug: Azacitidine (AZA)Drug: Placebo
Primary outcomes
  • Percentage of Participants who Achieve Complete Remission (CR) (Up to 4 years and 1 month)
  • Overall Survival (OS) (Up to 4 years and 1 month)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (239)
Cancer Treatment Center of America PhoenixRecruiting
Goodyear, Arizona, United States
The University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
University of Arkansas at Little RockRecruiting
Little Rock, Arkansas, United States
City of HopeRecruiting
Duarte, California, United States
Jupiter ResearchRecruiting
Jupiter, Florida, United States
Orlando Health Cancer InstituteRecruiting
Orlando, Florida, United States
Moffit Cancer centerRecruiting
Tampa, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
University of Chicago MedicineRecruiting
Chicago, Illinois, United States
University of Kentucky Markey Cancer CenterRecruiting
Lexington, Kentucky, United States
UofL Health Brown Cancer CenterRecruiting
Louisville, Kentucky, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Washington University in St LouisRecruiting
St Louis, Missouri, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer CenterRecruiting
Buffalo, New York, United States
New York Presbyterian - Weill CornellRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
Einstein-Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Atrium HealthRecruiting
Charlotte, North Carolina, United States
Novant Health CharlotteRecruiting
Charlotte, North Carolina, United States
Novant Health Winston SalemRecruiting
Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterRecruiting
Winston-Salem, North Carolina, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic WestsideRecruiting
Portland, Oregon, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
University of TennesseeRecruiting
Knoxville, Tennessee, United States
Vanderbilt Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Virginia Commonwealth University - Massey Cancer CenterRecruiting
Richmond, Virginia, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Flinders Medical CentreRecruiting
Bedford Park, Australia
Royal Prince Alfred HospitalRecruiting
Camperdown, Australia
St Vincents Hospital MelbourneRecruiting
Fitzroy, Australia
St George HospitalRecruiting
Kogarah, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Australia
Kepler Universitatsklinikum GmbHRecruiting
Linz, Austria
Ordensklinikum Linz GmbH ElisabethinenRecruiting
Linz, Austria
Universitaetsklinikum Salzburg LandeskrankenhausRecruiting
Salzburg, Austria
Medical University of Vienna Universitatsklinik fur Innere Medizin IRecruiting
Vienna, Austria
Wiener Gesundheitsverbund Klinik HietzingRecruiting
Vienna, Austria
Klinikum Wels GrieskirchenRecruiting
Wels, Austria
AZ Sint-JanRecruiting
Bruges, Belgium
UZ AntwerpenRecruiting
Edegem, Belgium
Ziekenhuis Oost-LimburgRecruiting
Genk, Belgium
Ghent University HospitalRecruiting
Ghent, Belgium
Chu Helora Hospital La Louviere Site JolimontRecruiting
La Louvière, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Clinique Saint PierreRecruiting
Ottignies, Belgium
Algemeen Ziekenhuis DeltaRecruiting
Roeselare, Belgium
Fundacao Pio XIIRecruiting
Barretos, Brazil
DF Star Rede D orRecruiting
Brasília, Brazil
Liga Paranaense de Combate ao CancerRecruiting
Curitiba, Brazil
Liga Norte Riograndense Contra O CancerRecruiting
Natal, Brazil
Ministerio da Saude Instituto Nacional do CancerRecruiting
Rio de Janeiro, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)Recruiting
Rio de Janeiro, Brazil
Real e Benemerita Associacao Portuguesa de BeneficenciaRecruiting
São Paulo, Brazil
Instituto D Or de Pesquisa e EnsinoRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Arthur J E Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Vancouver General HospitalRecruiting
Vancouver, British Columbia, Canada
Cancercare ManitobaRecruiting
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences CentreRecruiting
Halifax, Nova Scotia, Canada
Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
London Health Sciences Centre Victoria HospitalRecruiting
London, Ontario, Canada
Princess Margaret Cancer Centre University Health NetworkRecruiting
Toronto, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve RosemontRecruiting
Montreal, Quebec, Canada
Peking University First HospitalRecruiting
Beijing, China
Peking University People's HospitalRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
The first Affiliated Hospital of Jilin UniversityRecruiting
Changchun, China
Sichuan Provincial Peoples HospitalRecruiting
Chengdu, China
West China Hospital Si Chuan UniversityRecruiting
Chengdu, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, China
The First Affiliated Hospital Zhejiang University College of MedicineRecruiting
Hangzhou, China
The First Affiliated Hospital of USTC Anhui Provincial HospitalRecruiting
Hefei, China
Qilu Hospital of Shandong UniversityRecruiting
Jinan, China
The Second Hospital & Clinical Medical School Lanzhou UniversityRecruiting
Lanzhou, China
The First Affiliated Hospital of NanChang UniversityRecruiting
Nanchang, China
Zhongda Hospital Southeast UniversityRecruiting
Nanjing, China
The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
Shengjing Hospital Of China Medical UniversityRecruiting
Shenyang, China
The Second People's Hospital of ShenzhenRecruiting
Shenzhen, China
First Affiliated Hospital SooChow UniversityRecruiting
Suzhou, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting
Tijian, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, China
Union Hospital Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Wuhan, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & TechnologyRecruiting
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Xi'an, China
The first affiliated hospital of xiamen universityRecruiting
Xiamen, China
Henan Cancer HospitalRecruiting
Zhengzhou, China
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinikaRecruiting
Brno, Czechia
Fakultni nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Fakultni Nemocnice OstravaRecruiting
Ostrava - Poruba, Czechia
Fakultni nemocnice PlzenRecruiting
Pilsen, Czechia
Fakultni nemocnice Kralovske VinohradyRecruiting
Prague, Czechia
Ustav Hematologie A Krevni TransfuzeRecruiting
Prague, Czechia
Vseobecna Fakultní NemocniceRecruiting
Prague, Czechia
Aalborg University HospitalRecruiting
Aalborg, Denmark
Odense University HospitalRecruiting
Odense, Denmark
Zealand University HospitalRecruiting
Roskilde, Denmark
CHU d'AngersRecruiting
Angers, France
CHU de Clermont Ferrand - Site EstaingRecruiting
Clermont-Ferrand, France
Hopital Saint Vincent de PaulRecruiting
Lille, France
Institut Paoli CalmettesRecruiting
Marseille, France
CHU de Montpellier Hopital Saint EloiRecruiting
Montpellier, France
CHU De Nice Hopital De l'ArchetRecruiting
Nice, France
Hopital Saint LouisRecruiting
Paris, France
CHU Lyon SudRecruiting
Pierre-Bénite, France
CHU Reims Hopital Robert DebreRecruiting
Reims, France
Chu Rennes Hopital PontchaillouRecruiting
Rennes, France
Institut Universitaire du Cancer Toulouse OncopoleRecruiting
Toulouse, France
CHRU de Nancy - Hopitaux de BraboisRecruiting
Vandœuvre Ies-Nancy, France
Institut Gustave RoussyRecruiting
Villejuif, France
Klinikum AugsburgRecruiting
Augsburg, Germany
Universitaetsklinikum KoelnRecruiting
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
Dresden, Germany
Universitaetsklinikum FrankfurtRecruiting
Frankfurt, Germany
Universitaetsklinikum FreiburgRecruiting
Freiburg im Breisgau, Germany
Universitaetsklinikum Hamburg EppendorfRecruiting
Hamburg, Germany
Universitaetsklinikum HeidelbergRecruiting
Heidelberg, Germany
Universitaetsklinikum Schleswig Holstein Campus KielRecruiting
Kiel, Germany
Universitaetsklinikum LeipzigRecruiting
Leipzig, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
University Hospital of AlexandroupolisRecruiting
Alexandroupoli, Greece
Evaggelismos HospitalRecruiting
Athens, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia VarvaraRecruiting
Chaïdári, Greece
University General Hospital of IoanninaRecruiting
Ioannina, Greece
General University Hospital of PatrasRecruiting
Rio, Greece
Ahepa University General Hospital of ThessalonikiRecruiting
Thessaloniki, Greece
Geniko Nosokomeio Thessalonikis George PapanikolaouRecruiting
Thessaloniki, Greece
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Shamir Medical Center Assaf HarofehRecruiting
Beer Yaakov, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Carmel Medical CenterRecruiting
Haifa, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Hadassah University Hospita Ein KeremRecruiting
Jerusalem, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
ASST Papa Giovanni XXIII BergamoRecruiting
Bergamo, Italy
A O U Sant Orsola MalpighiRecruiting
Bologna, Italy
Azienda Ospedaliera Spedali Civili di BresciaRecruiting
Brescia, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
Meldola, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, Italy
ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della MisericordiaRecruiting
Perugia, Italy
AST Pesaro e Urbino Ospedale San SalvatoreRecruiting
Pesaro, Italy
Ospedale S. Maria Delle CrociRecruiting
Ravenna, Italy
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio CalabriaRecruiting
Reggio Calabria, Italy
IRCCS Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Casa Sollievo Della Sofferenza IRCCSRecruiting
San Giovanni Rotondo, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di TorinoRecruiting
Torino, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting
Bunkyō City, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Fukushima Medical University HospitalRecruiting
Fukushima, Japan
Gifu Municipal HospitalRecruiting
Gifu, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Japan
Kobe City Medical Center General HospitalRecruiting
Kobe, Japan
National Hospital Organization Kumamoto Medical CenterRecruiting
Kumamoto, Japan
Gunmaken Saiseikai Maebashi HospitalRecruiting
Maebashi, Japan
Nagoya University HospitalRecruiting
Nagoya, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Japanese Red Cross Osaka HospitalRecruiting
Osaka, Japan
Aiiku HospitalRecruiting
Sapporo, Japan
Tohoku University HospitalRecruiting
Sendai, Japan
Nippon Medical School HospitalRecruiting
Tokyo, Japan
Yamagata University HospitalRecruiting
Yamagata, Japan
University of Fukui HospitalRecruiting
Yoshida, Japan
Centro de Investigacion Clinica ChapultepecRecruiting
Mexico City, Mexico
Instituto Nacional de CancerologiaRecruiting
Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting
Mexico City, Mexico
Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
Bialystok, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w KielcachRecruiting
Kielce, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w LodziRecruiting
Lodz, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuRecruiting
Wroclaw, Poland
Uls Sao Jose - Hosp. Sto Antonio Dos CapuchosRecruiting
Lisbon, Portugal
Uls Santa Maria Hosp. Santa MariaRecruiting
Lisbon, Portugal
Uls Santo Antonio - Hosp. Santo AntonioRecruiting
Porto, Portugal
Instituto Portugues de Oncologia PortoRecruiting
Porto, Portugal
Uls Sao Joao - Hosp. Sao JoaoRecruiting
Porto, Portugal
Chungnam National University HospitalRecruiting
Daejeon, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Seoul National University Bundang HospitalRecruiting
Gyeonggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea Seoul St Marys HospitalRecruiting
Seoul, South Korea
Hosp Univ A CorunaRecruiting
A Coruña, Spain
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp. Clinic de BarcelonaRecruiting
Barcelona, Spain
Hosp. de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hosp. San Pedro de AlcantaraRecruiting
Cáceres, Spain
Hosp. de Jerez de La FronteraRecruiting
Jerez de la Frontera, Spain
Inst. Cat. Doncologia-H Duran I ReynalsRecruiting
L'Hospitalet de Llobregat, Spain
Clinica Univ. de Navarra MadridRecruiting
Madrid, Spain
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Clinica Univ. de NavarraRecruiting
Pamplona, Spain
Hosp. Quiron Madrid PozueloRecruiting
Pozuelo de Alarcón, Spain
Hosp Clinico Univ de SalamancaRecruiting
Salamanca, Spain
Hosp. Univ. Marques de ValdecillaRecruiting
Santander, Spain
Hosp. Virgen Del RocioRecruiting
Seville, Spain
Hosp. Univ. I Politecni La FeRecruiting
Valencia, Spain
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Chi Mei Medical Center Liouying BranchRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
Ankara Etlik Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Ankara University School of Medicine Cebeci HospitalRecruiting
Ankara, Turkey (Türkiye)
Memorial Antalya HospitalRecruiting
Antalya, Turkey (Türkiye)
Koc University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
VM Medical Park Mersin HospitalRecruiting
Mersin, Turkey (Türkiye)
Sakarya University Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Ondokuz Mayis UniversityRecruiting
Samsun, Turkey (Türkiye)
Royal Sussex County HospitalRecruiting
Brighton, United Kingdom
Addenbrookes HospitalRecruiting
Cambridge, United Kingdom
Kent and Canterbury HospitalRecruiting
Canterbury, United Kingdom
Colchester Hospital University NHSRecruiting
Colchester, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
The Clatterbridge Cancer CentreRecruiting
Liverpool, United Kingdom
Guys' and St Thomas' NHS TrustRecruiting
London, United Kingdom
Derriford HospitalRecruiting
Plymouth, United Kingdom
Worthing HospitalRecruiting
Worthing, United Kingdom