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

NCT04811560

RecruitingPhase 1, Phase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Acute Leukemia

Interventions: Bleximenib

Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Israel

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 overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (102)
  • Duarte, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Albuquerque, New Mexico, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Knoxville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Richmond, Virginia, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Clayton, Australia
  • Perth, Australia
  • Southport, Australia
  • Ghent, Belgium
  • + 72 more on CT.gov