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

Recruiting now · Phase 1/Phase 2

Conditions studied: Acute Leukemia

In brief

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.

Key facts

Study ID

NCT04811560

Run by

Janssen Research & Development, LLC

People needed

420

Starts

2021-05-19

Expected to finish

2030-09-22

Last updated by the study team

2026-07-31

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Monash Medical Centre — Clayton, Australia (enrolling)
• Royal Perth Hospital — Perth, Australia (enrolling)
• Medical College of WI at Froedtert — Milwaukee, Wisconsin, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• UCSF Benioff Children's Hospital — San Francisco, California, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Start Midwest — Grand Rapids, Michigan, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• NYU Langone Medical Center — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Oregon Health And Science University — Portland, Oregon, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Maine Health — Providence, Rhode Island, United States (enrolling)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
• Baylor University Medical Center — Dallas, Texas, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• San Antonio Methodist TX Transplant Physicians Group — San Antonio, Texas, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)
• Gold Coast University Hospital — Southport, Australia (enrolling)

Full record on ClinicalTrials.gov

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