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

Status: Recruiting
Location: See all (164) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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) 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

Locations
United States
Arkansas
University of Arkansas at Little Rock
RECRUITING
Little Rock
Florida
Orlando Health Cancer Institute
RECRUITING
Orlando
Moffit Cancer center
RECRUITING
Tampa
Cleveland Clinic Florida
RECRUITING
Weston
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Missouri
Washington University in St Louis
RECRUITING
St Louis
North Carolina
Atrium Health
RECRUITING
Charlotte
Novant Health
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Novant Health
RECRUITING
Winston-salem
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Gabrail Cancer Center
RECRUITING
Canton
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Providence Oncology and Hematology Care Clinic Westside
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Tennessee
University of Tennessee
RECRUITING
Knoxville
Texas
Baylor University Medical Center
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Royal Prince Alfred Hospital
RECRUITING
Camperdown
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
St George Hospital
RECRUITING
Kogarah
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Belgium
AZ Sint-Jan
RECRUITING
Bruges
UZ Antwerpen
RECRUITING
Edegem
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Ghent University Hospital
RECRUITING
Ghent
Chu Helora Hospital La Louviere Site Jolimont
RECRUITING
La Louvière
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Clinique Saint Pierre
RECRUITING
Ottignies
Algemeen Ziekenhuis Delta
RECRUITING
Roeselare
Brazil
Fundacao Pio XII
RECRUITING
Barretos
Instituto D Or de Pesquisa e Ensino
RECRUITING
Brasília
Liga Paranaense de Combate ao Cancer
RECRUITING
Curitiba
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Instituto D Or de Pesquisa e Ensino
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Canada
Arthur J E Child Comprehensive Cancer Centre
RECRUITING
Calgary
London Health Sciences Centre Victoria Hospital
RECRUITING
London
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
RECRUITING
Montreal
Princess Margaret Cancer Centre University Health Network
RECRUITING
Toronto
China
Peking University First Hospital
RECRUITING
Beijing
Peking University People s Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The first Affiliated Hospital of Jilin University
RECRUITING
Changchun
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
West China Hospital Si Chuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
The Second People's Hospital of Shenzhen
RECRUITING
Shenzhen
First Affiliated Hospital SooChow University
RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tijian
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Odense University Hospital
RECRUITING
Odense
Zealand University Hospital
RECRUITING
Roskilde
France
CHU d'Angers
RECRUITING
Angers
CHU de Clermont Ferrand - Site Estaing
RECRUITING
Clermont-ferrand
Hopital Saint Vincent de Paul
RECRUITING
Lille
Institut Paoli Calmettes
RECRUITING
Marseille
Hopital Saint Louis
RECRUITING
Paris
CHU Lyon Sud
RECRUITING
Pierre-bénite
CHU Reims Hopital Robert Debre
RECRUITING
Reims
Institut Universitaire du Cancer Toulouse Oncopole
RECRUITING
Toulouse
Germany
Klinikum Augsburg
RECRUITING
Augsburg
Universitaetsklinikum Carl Gustav Carus TU Dresden
RECRUITING
Dresden
Universitaetsklinikum Frankfurt
RECRUITING
Frankfurt
Universitaetsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Greece
University Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
Evaggelismos Hospital
RECRUITING
Athens
General Hospital of Athens Attikon
RECRUITING
Chaïdári
University General Hospital of Ioannina
RECRUITING
Ioannina
General University Hospital of Patras
RECRUITING
Rio
Ahepa University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Geniko Nosokomeio Thessalonikis George Papanikolaou
RECRUITING
Thessaloniki
Israel
Shamir Medical Center Assaf Harofeh
RECRUITING
Beer Yaakov
Carmel Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Hadassah University Hospita Ein Kerem
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
ASST Papa Giovanni XXIII Bergamo
RECRUITING
Bergamo
A O U Sant Orsola Malpighi
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING
Brescia
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale S. Maria Delle Croci
RECRUITING
Ravenna
Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
RECRUITING
Reggio Calabria
Casa Sollievo Della Sofferenza IRCCS
RECRUITING
San Giovanni Rotondo
Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
RECRUITING
Bunkyō City
Kyushu University Hospital
RECRUITING
Fukuoka
Fukushima Medical University Hospital
RECRUITING
Fukushima
Gifu Municipal Hospital
RECRUITING
Gifu
Kobe City Medical Center General Hospital
RECRUITING
Kobe
National Hospital Organization Kumamoto Medical Center
RECRUITING
Kumamoto
Gunmaken Saiseikai Maebashi Hospital
RECRUITING
Maebashi
Nagoya University Hospital
RECRUITING
Nagoya
Okayama University Hospital
RECRUITING
Okayama
Japanese Red Cross Osaka Hospital
RECRUITING
Osaka
Aiiku Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Nippon Medical School Hospital
RECRUITING
Tokyo
Yamagata University Hospital
RECRUITING
Yamagata
University of Fukui Hospital
RECRUITING
Yoshida
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
RECRUITING
Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
RECRUITING
Wroclaw
Portugal
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
RECRUITING
Lisbon
Instituto Portugues de Oncologia
RECRUITING
Porto
Uls Santo Antonio - Hosp. Santo Antonio
RECRUITING
Porto
Uls Sao Joao - Hosp. Sao Joao
RECRUITING
Porto
Republic of Korea
Chungnam National University Hospital
RECRUITING
Daejeon
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Gyeonggi-do
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. San Pedro de Alcantara
RECRUITING
Cáceres
Clinica Univ. de Navarra
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Clinica Univ. de Navarra
RECRUITING
Pamplona
Hosp. Quiron Madrid Pozuelo
RECRUITING
Pozuelo De Alarcón
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
Hosp. Univ. Marques de Valdecilla
RECRUITING
Santander
Hosp. Virgen Del Rocio
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Chi Mei Medical Center Liouying Branch
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara Etlik Sehir Hastanesi
RECRUITING
Ankara
Ankara University School of Medicine Cebeci Hospital
RECRUITING
Ankara
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Ankara
Memorial Antalya Hospital
RECRUITING
Antalya
Koc University Medical Faculty
RECRUITING
Istanbul
VM Medical Park Mersin Hospital
RECRUITING
Mersin
Sakarya University Training and Research Hospital
RECRUITING
Sakarya
Ondokuz Mayis University
RECRUITING
Samsun
United Kingdom
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
Addenbrookes Hospital
RECRUITING
Cambridge
Kent and Canterbury Hospital
RECRUITING
Canterbury
Western General Hospital
RECRUITING
Edinburgh
The Clatterbridge Cancer Centre
RECRUITING
Liverpool
Derriford Hospital
RECRUITING
Plymouth
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Worthing
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2029-08-15
Participants
Target number of participants: 600
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov