Status:
RECRUITING
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Acute Leukemias
Acute Myeloid Leukemia
Eligibility:
All Genders
2+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility 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)
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 22 2030
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04811560
Start Date
May 19 2021
End Date
September 22 2030
Last Update
April 14 2026
Active Locations (103)
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1
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
2
City of Hope
Duarte, California, United States, 91010
3
University of California Irvine Medical Center
Orange, California, United States, 92868
4
University of California San Francisco
San Francisco, California, United States, 94143