Study on Azacitidine and Venetoclax for Treating Acute Myeloid Leukemia (AML)

Inclusion Criteria

• Adults aged 18 or older.
• Willing and able to follow the study schedule and requirements.
• Diagnosed with a specific type of AML (not APL) according to medical guidelines.
• Completed 2 cycles of intensive chemotherapy.
• In remission with less than 5% cancer cells in the bone marrow.
• Have positive measurable residual disease (MRD) at specified levels.
• Eligible for intensive chemotherapy and a stem cell transplant after the trial.
• Have a performance status score of 3 or lower, indicating ability to perform daily activities.
• Have adequate organ function based on specific blood tests.
• No active uncontrolled infections, heart failure, or severe psychiatric or neurological conditions.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 6 months after the last dose of azacitidine. Men with female partners of reproductive potential should use effective contraception during treatment and for 3 months after.

Exclusion Criteria

• Have acute promyelocytic leukemia (APL) or relapsed/refractory AML.
• Have blast crisis of chronic myeloid leukemia.
• Have 5% or more cancer cells in the bone marrow.
• Have not recovered blood counts to specified levels.
• Have previously received treatment with venetoclax.
• Have any condition that increases risk or makes participation inappropriate.
• Have active uncontrolled infections.
• Have had recent significant blood clots or need for full anticoagulation.
• Have a mechanical heart valve.
• Have had recent significant bleeding.
• Have significant active heart disease within 6 months.
• Have conditions that limit the ability to take oral medications.
• Are pregnant or breastfeeding.