Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia

Exclusion Criteria

• •A subject will not be eligible for study participation if he/she meets any of the following criteria:
• •1. Subject has received disease modifying treatment for myelodysplastic syndrome (MDS) or AML. ATRA given for clinical suspicion of APL will not be exclusionary and no washout will be required in this scenario.
• •2. Subject is known to be positive for HIV. HIV testing is not required.
• •3. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag-, anti-HBs+ and anti-HBc-) may participate
• •4. Subject has received within 7 days prior to the first dose of study drug:steroid therapy for anti-neoplastic intent; strong and moderate CYP3A inhibitors; strong and moderate CYP3A inducers.
• •5. Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.
• •6. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
• •* New York Heart Association heart failure \> class 2
• •* Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia
• •7. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration
• •8. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)
• •9. Subject has a history of other malignancies prior to study entry, with the exception of:
• •* Adequately treated in situ carcinoma of the breast or cervix uteri
• •* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
• •* Prostate cancer with no plans for therapy of any kind
• •* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• •10. Subject has a white blood cell count \>25 × 10\^9/L or absolute blast count of \>50 10\^9/L. Hydroxyurea and leukapheresis are permitted, if clinically indicated.
• •11. Patients willing to receive intensive induction chemotherapy
• •12. Pregnant and breastfeeding females.