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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT04811560

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Bleximenib (Drug)
    Bleximenib is administered orally.

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)

Conditions

Acute Leukemia

Locations

  • 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
  • Ghent University Hospital — Ghent, Belgium
  • IDOR - Regional Brasilia — 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
  • IDOR - Regional Sao Paulo — 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
  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre — 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
  • Hospital Infantil Universitario Nino Jesus — 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record