A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Trial Status: active
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.
Inclusion Criteria
- Inclusion Criteria: Phase 1: - 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: - 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)
Additional locations may be listed on ClinicalTrials.gov for NCT04811560.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not AvailableMassachusetts General Hospital Cancer Center
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMichigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Active
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Name Not AvailableNew York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not AvailableBuffalo
Roswell Park Cancer Institute
Status: Active
Name Not AvailableNew York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Philadelphia
Temple Health Jeanes Hospital
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableVirginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase I/II
Trial Typetreatment
Lead OrganizationJanssen Research & Development, LLC
- Primary IDCR108998
- Secondary IDsNCI-2021-05696, 2020-005967-30, 2023-506581-31-00, 75276617ALE1001
- ClinicalTrials.gov IDNCT04811560