A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
- Acute Leukemia
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 420
- Started
- 19 May 2021
- Main results due
- 26 February 2027
- Study sites
- 102
- Registry updated
- 25 September 2026
Can you take part?
- Aged 2 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: Phase 1: * Age 2 years to less than (\<) 18 years of age (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 \<= 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate \>= 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>=40 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 \< 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: * Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 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 * Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement) * 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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(102)
City of Hope
Duarte, California, United States
Recruiting
University of California Irvine Medical Center
Orange, California, United States
Completed
University of California San Francisco
San Francisco, California, United States
Recruiting
UCSF Benioff Children's Hospital
San Francisco, California, United States
Recruiting
University of Chicago
Chicago, Illinois, United States
Recruiting
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Recruiting
Norton Cancer Institute
Louisville, Kentucky, United States
Completed
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Completed
Start Midwest
Grand Rapids, Michigan, United States
Recruiting
University of New Mexico
Albuquerque, New Mexico, United States
Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Recruiting
NYU Langone Medical Center
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Completed
Maine Health
Providence, Rhode Island, United States
Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Recruiting
Baylor University Medical Center
Dallas, Texas, United States
Recruiting
Houston Methodist Hospital
Houston, Texas, United States
Recruiting
MD Anderson
Houston, Texas, United States
Recruiting
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, United States
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Swedish Cancer Institute
Seattle, Washington, United States
Recruiting
Medical College of WI at Froedtert
Milwaukee, Wisconsin, United States
Recruiting
Monash Medical Centre
Clayton, Australia
Recruiting
Royal Perth Hospital
Perth, Australia
Recruiting
Gold Coast University Hospital
Southport, Australia
Recruiting
Ghent University Hospital
Ghent, Belgium
Recruiting
IDOR - Regional Brasilia
Brasília, Brazil
Recruiting
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Recruiting
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Recruiting
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Recruiting
IDOR - Regional Sao Paulo
São Paulo, Brazil
Recruiting
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Recruiting
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Recruiting
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Recruiting
Peking University First Hospital
Beijing, China
Recruiting
The First Hospital of Jilin University
Changchun, China
Recruiting
West China Hospital Si Chuan University
Chengdu, China
Recruiting
Nanfang Hospital of Southern Medical Hospital
Guangzhou, China
Completed
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, China
Recruiting
Qilu Hospital of Shandong University
Jinan, China
Recruiting
The First Affiliated Hospital of NanChang University
Nanchang, China
Recruiting
Zhongda Hospital Southeast University
Nanjing, China
Recruiting
Institute of Hematology and Blood Diseases Hospital
Tianjin, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Recruiting
Henan Cancer Hospital
Zhengzhou, China
Recruiting
Hopital Jean Minjoz
Besançon, France
Recruiting
Institut Paoli Calmettes
Marseille, France
Recruiting
CHU de Nantes hotel Dieu
Nantes, France
Recruiting
Hopital Saint Louis
Paris, France
Recruiting
Hopital trousseau- APHP
Paris, France
Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie
Pessac, France
Completed
CHU Lyon Sud
Pierre-Bénite, France
Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Recruiting
Showing 60 of 102 sites — filter to narrow it down. 85 of the 102 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04811560. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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