Pilot Study on Adding Venetoclax to Standard Chemotherapy for Treating Secondary Acute Myeloid Leukemia

Inclusion Criteria

• Diagnosed with secondary acute myeloid leukemia (AML) as defined by specific medical criteria.
• AML developed after other blood disorders like aplastic anemia, myelodysplastic syndrome, or myeloproliferative neoplasms.
• AML with specific genetic changes or therapy-related AML.
• No prior treatment for secondary AML, except for hydroxyurea or leukopheresis.
• Previous treatment for related blood disorders is allowed.
• Aged 18 years or older.
• In good general health with an ECOG performance status of 0 to 2.
• Able to understand and sign a consent form.
• Have adequate organ function based on specific blood tests.
• Must be non-fertile or agree to use effective contraception during and for 6 months after the study.
• Able to comply with all study requirements.

Exclusion Criteria

• Diagnosed with specific types of leukemia, such as acute promyelocytic leukemia or myeloid blast phase of chronic myeloid leukemia.
• Have a white blood cell count over 50,000 at the start of therapy, unless reduced beforehand.
• Receiving other anti-leukemic treatments, except for certain allowed medications.
• Previous treatment with a Bcl-2 antagonist.
• Allergic to any of the study drugs.
• Active leptomeningeal leukemia.
• Known history of HIV, Hepatitis B, or Hepatitis C, unless under control.
• Active second cancer requiring treatment within 3 months, except for certain skin or cervical cancers.
• Active uncontrolled infection or other medical conditions interfering with the study.
• Pregnant or breastfeeding women.
• Men and women of childbearing potential must use effective birth control during and for 6 months after the study.
• Received live vaccines within 28 days before starting the study.
• Consumed certain foods or medications that interfere with the study drugs within specified timeframes.
• Have certain heart or lung conditions.
• Have a condition that prevents taking oral medications.