Study on Azacitidine or Decitabine with Venetoclax for Acute Myeloid Leukemia After Previous Treatment Failure

Inclusion Criteria

• Must be able to understand and sign a consent form.
• Diagnosed with acute myeloid leukemia (AML) according to specific medical criteria.
• Aged 18 years or older.
• Newly diagnosed and eligible for treatment with venetoclax and HMA, either aged 75 or older, or aged 18-74 with certain health conditions such as:
  • Moderate heart issues or low heart function.
  • Breathing difficulties.
  • Reduced kidney function.
  • Moderate liver issues.
  • Any other condition that makes intensive chemotherapy unsuitable.
• Previously treated with HMA for a blood disorder before joining the study, with either no improvement or a return of the disease after initial response.
• Must not have received treatment for AML before.
• Previous bone marrow transplant is allowed if done at least 3 months prior and there is no active graft versus host disease.
• Must have a certain level of physical health, as measured by a performance status score.
• Must have specific blood cell counts and organ function levels.
• Women of childbearing potential and men with partners of childbearing potential must agree to use effective birth control during the study and for 90 days after.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.
• Must be able to swallow pills.

Exclusion Criteria

• Cannot use other experimental drugs within 14 days before starting the study treatment.
• Cannot have a type of leukemia called acute promyelocytic leukemia.
• Cannot have active leukemia in the central nervous system.
• Cannot have had certain cancer treatments within 14 days before starting the study treatment.
• Cannot have been treated with venetoclax before.
• Cannot have active HIV or hepatitis infections unless under control.
• Cannot use certain medications that affect drug metabolism within 7 days before starting the study treatment.
• Cannot consume grapefruit, Seville oranges, or starfruit within 3 days before starting the study treatment.
• Cannot have severe or uncontrolled medical conditions that would interfere with the study treatment.
• Cannot have a history of other cancers unless treated and inactive for at least 1 year.
• Cannot have active infections requiring treatment.
• Cannot have allergies to similar drugs used in the study.
• Cannot have conditions that prevent taking oral medication.
• Cannot have severe heart conditions.
• Cannot be pregnant or nursing.