Study on Bleximenib for Patients with Acute Leukemia

Inclusion Criteria

Phase 1:

• Have acute leukemia that has returned or not responded to other treatments, and no other treatment options are available.
• Be between 12 and 18 years old and weigh at least 40 kg for the adolescent group.
• Have specific genetic changes in the leukemia cells (KMT2A, NPM1, NUP98, or NUP214).

Phase 2:

• Be over 18 years old.
• Have been diagnosed with acute myeloid leukemia (AML) according to the latest criteria.
• Have specific genetic changes in the leukemia cells (KMT2A-r or NPM1 mutations).

For Both Phases:

• Have certain blood and kidney function levels within specified limits.
• Be in good general health with a performance status score of 0, 1, or 2. Adolescents must have a performance status of at least 70 on the Lansky or Karnofsky scale, depending on age.
• Women of childbearing potential must have a negative pregnancy test before starting the study.
• Agree to use effective birth control methods during the study and for 90 days after the last dose, including using condoms and not donating sperm.

Exclusion Criteria

• Have certain types of leukemia, such as acute promyelocytic leukemia, Down syndrome-associated leukemia, or juvenile myelomonocytic leukemia.
• Have active disease in the central nervous system.
• Have had a solid organ transplant.
• Have a heart condition known as Long QT syndrome or a family history of it.
• Have had a stem cell transplant within the last 3 months or have complications from it.
• Have received certain cancer treatments recently, including immunotherapy within 4 weeks or blinatumomab within 2 weeks before joining the study.