Last updated 36 days ago
A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia
400 patients around the world
Available in Brazil, United States
Janssen Research & Development, LLC
1Research sites
400Patients around the world
This study is for people with
Leukemia
Acute lymphoblastic leukemia
Acute myeloid leukemia
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options.Participants greater than or equal to 12 and less than 18 years of age are only eligible for the Phase 1 adolescent cohort.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.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.Pretreatment clinical laboratory values meeting the following criteria: Hematology: white blood cell (WBC) count less than or equal to 20*10^9/liter (L) and renal function; Estimated or measured glomerular filtration rate greater than or equal to 50 milliliter per minute (mL/min) per four variable modified diet in renal disease (MDRD) equation.Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status greater than or equal to 70 by Lansky scale (for participants less than 16 years of age) or greater than or equal to 70 Karnofsky scale (for participants greater than or equal to 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.
- 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 greater than or equal to 450 millisecond (msec) or for females greater than or equal to 470 msec. Participants with a family history of Long QT syndrome are excluded.Exclusion criteria related to stem cell transplant:Received prior treatment with allogenic bone marrow or stem cell transplant less than or equal to 3 months before the first dose of study treatment.Exclusion criteria related to stem cell transplant: Has evidence of graft versus host disease.Exclusion criteria related to stem cell transplant: Received donor lymphocyte infusion less than or equal to 1 month before the first dose of study treatment.Exclusion criteria related to stem cell transplant: Requires immunosuppressant therapy (exception: daily doses less than or equal to 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).
Sites
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Acute lymphoblastic leukemiaAcute myeloid leukemia
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04811560
