Study on the Safety and Effectiveness of ASTX727 and Venetoclax for Treating Acute Myeloid Leukemia (AML)

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of newly diagnosed acute myeloid leukemia (AML).
• Expected to live for at least 3 more months.
• Cannot receive intensive chemotherapy due to age (75 or older) or other health conditions like severe heart or lung problems, moderate liver issues, or reduced kidney function.
• Must be in relatively good health with a performance status score of 0 to 3, depending on the study phase.
• Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
• Participants and their partners must agree to use effective birth control during the study and for 3 months after the last treatment.
• Must be able to understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

• Have a history of certain blood disorders or specific genetic abnormalities.
• Have active involvement of the central nervous system by AML.
• Have active HIV, hepatitis B, or hepatitis C infections.
• Have severe liver or kidney problems.
• Have conditions that prevent taking medications by mouth.
• Have significant heart or lung diseases.
• Have uncontrolled infections or other serious medical conditions.
• Have had other cancers, except for certain treated skin cancers or early-stage cancers.
• Have a high white blood cell count unless treated to lower it.
• Have received certain treatments for blood disorders or AML before.
• Cannot stop taking certain medications that interact with the study drugs.
• Are participating in another clinical trial.
• Have allergies to the study drugs or their ingredients.
• Have mental health issues or substance abuse problems that affect study participation.
• Consume grapefruit, Seville oranges, or starfruit within 7 days before starting the study.