A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
NCT ID: NCT04811560
Last Updated: 2026-01-16
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
PHASE1/PHASE2
400 participants
INTERVENTIONAL
2021-05-19
2028-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Bleximenib
Participants in Phase 1 Part 1 (dose escalation) will receive bleximenib orally. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Doses (RP2Ds) have been identified. Participants in Phase 1 Part 2 (dose expansion) will receive bleximenib orally at the RP2D(s) determined in Part 1. In Phase 2 participants will receive bleximenib at the RP2D to evaluate anti-leukemia activity and demonstrate acceptable safety at the RP2D(s).
Bleximenib
Bleximenib is administered orally.
Interventions
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Bleximenib
Bleximenib is administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above
* Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options
* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations
Phase: 2
* Participants greater than 18 years are eligible
* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease
* AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only
For Both Phase 1 and 2:
* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>50 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants less than \[\<\]16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age)
* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria
* Active central nervous system (CNS) disease
* Prior solid organ transplantation
* QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded
* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
2 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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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
Countries
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Central Contacts
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References
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Kwon MC, Thuring JW, Querolle O, Dai X, Verhulst T, Pande V, Marien A, Goffin D, Wenge DV, Yue H, Cutler JA, Jin C, Perner F, Hogeling SM, Shaffer PL, Jacobs F, Vinken P, Cai W, Keersmaekers V, Eyassu F, Bhogal B, Verstraeten K, El Ashkar S, Perry JA, Jayaguru P, Barreyro L, Kuchnio A, Darville N, Krosky D, Urbanietz G, Verbist B, Edwards JP, Cowley GS, Kirkpatrick R, Steele R, Ferrante L, Guttke C, Daskalakis N, Pietsch EC, Wilson DM, Attar R, Elsayed Y, Fischer ES, Schuringa JJ, Armstrong SA, Packman K, Philippar U. Preclinical efficacy of the potent, selective menin-KMT2A inhibitor JNJ-75276617 (bleximenib) in KMT2A- and NPM1-altered leukemias. Blood. 2024 Sep 12;144(11):1206-1220. doi: 10.1182/blood.2023022480.
Other Identifiers
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75276617ALE1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506581-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108998
Identifier Type: -
Identifier Source: org_study_id
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