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A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.
Official title: A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2021-05-19
Completion Date
2028-05-26
Last Updated
2026-01-16
Healthy Volunteers
No
Interventions
Bleximenib
Bleximenib is administered orally.
Locations (101)
City of Hope Phoenix
Goodyear, Arizona, United States
City of Hope
Duarte, California, United States
University of California Irvine Medical Center
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Start Midwest
Grand Rapids, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
NYU Langone Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oregon Health And Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Maine Health
Providence, Rhode Island, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
MD Anderson
Houston, Texas, United States
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Medical College of WI at Froedtert
Milwaukee, Wisconsin, United States
Monash Medical Centre
Clayton, Australia
Royal Perth Hospital
Perth, Australia
Gold Coast University Hospital
Southport, Australia
Instituto D Or de Pesquisa e Ensino
Brasília, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Peking University First Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital Si Chuan University
Chengdu, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, China
Qilu Hospital of Shandong University
Jinan, China
The First Affiliated Hospital of NanChang University
Nanchang, China
Zhongda Hospital Southeast University
Nanjing, China
Institute of Hematology and Blood Diseases Hospital
Tianjin, 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
Henan Cancer Hospital
Zhengzhou, China
Hopital Jean Minjoz
Besançon, France
Institut Paoli Calmettes
Marseille, France
CHU de Nantes hotel Dieu
Nantes, France
Hopital Saint Louis
Paris, France
Hopital trousseau- APHP
Paris, France
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
Pessac, France
CHU Lyon Sud
Pierre-Bénite, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
CHU Bretonneau
Tours, France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, France
Carmel Medical Center
Haifa, Israel
Hadassah University Hospita Ein Kerem
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Kyushu University Hospital
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Kanazawa University Hospital
Kanazawa, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Japan
Nagoya University Hospital
Nagoya, Japan
Hokkaido University Hospital
Sapporo, Japan
NTT Medical Center Tokyo
Tokyo, Japan
Yamagata University Hospital
Yamagata, Japan
University of Fukui Hospital
Yoshida, Japan
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Hosp. Clinico Univ. de Valencia
Valencia, Spain
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
University Hospital of Wales
Cardiff, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
University College London Hospitals
London, United Kingdom
The Christie Nhs Foundation Trust
Manchester, United Kingdom
Oxford University Hospitals NHS Trust
Oxfordshire, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom