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Clinical Trials in the UK / NCT04811560
Recruiting Phase 1/2

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

NCT04811560 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1/2
Started
2021-05-19
Last updated
2026-08-28

Condition(s) studied

Acute Leukemia

Investigational drug(s) / intervention(s)

Bleximenib

Bleximenib: Bleximenib is administered orally.

Study 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (102)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
University of California Irvine Medical Center Orange California Completed
University of California San Francisco San Francisco California Recruiting
UCSF Benioff Children's Hospital San Francisco California Recruiting
University of Chicago Chicago Illinois Recruiting
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis Indiana Recruiting
Norton Cancer Institute Louisville Kentucky Completed
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Completed
Start Midwest Grand Rapids Michigan Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
NYU Langone Medical Center New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Oregon Health And Science University Portland Oregon Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Completed
Maine Health Providence Rhode Island Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
Baylor University Medical Center Dallas Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
MD Anderson Houston Texas Recruiting
San Antonio Methodist TX Transplant Physicians Group San Antonio Texas Recruiting
Virginia Commonwealth University Richmond Virginia Recruiting
Swedish Cancer Institute Seattle Washington Recruiting
Medical College of WI at Froedtert Milwaukee Wisconsin 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 Recruiting
Princess Margaret Cancer Centre University Health Network Toronto Ontario Recruiting
Hopital Maisonneuve Rosemont Montreal Quebec Recruiting
Peking University First Hospital Beijing China Recruiting

+ 62 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04811560 on ClinicalTrials.gov ↗ ← All trials in the UK