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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 be able to join 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

🚫 You may not be able to join if…

• 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 this trial is running

• 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

+ 90 more sites.

Who to contact

Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04811560.