Study on Venetoclax and Azacitidine for Younger Adults with Untreated Acute Myeloid Leukemia

Inclusion Criteria

• Must have a confirmed diagnosis of acute myeloid leukemia (AML) that is not a specific subtype called APL.
• Must not have received any prior treatment for AML.
• Must be between 18 and 59 years old.
• Must not have active disease in the central nervous system.
• Must have a performance status score of 0 to 2, indicating good overall health.
• Must have adequate kidney function, with a creatinine clearance of at least 30 mL/min.
• Must have adequate liver function, with specific liver enzyme levels within acceptable limits.
• Male participants must use contraception and avoid donating sperm during and for 90 days after treatment.
• Female participants of childbearing potential must use two forms of contraception or abstain from sex during and for 90 days after treatment.
• Must sign an informed consent form to participate in the study.
• Must have a specific risk level of disease as defined by medical guidelines.

Exclusion Criteria

• Have received treatment for myelodysplastic syndrome (MDS) or AML, except for a specific scenario involving APL.
• Have a known positive test for HIV.
• Have a known positive test for hepatitis B or C, unless the viral load is undetectable.
• Have taken certain medications or consumed specific fruits that interact with the study drugs within a specified time before starting the study.
• Have significant medical conditions that could affect participation, such as severe heart failure or other serious diseases.
• Have a condition that affects the absorption of oral medications.
• Have an uncontrolled infection requiring treatment.
• Have a history of other cancers, except for certain types that have been treated and are not expected to return.
• Have a high white blood cell count, unless treated with specific medications or procedures.
• Be willing to receive intensive chemotherapy.
• Be pregnant or breastfeeding.