A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy

Inclusion Criteria:

• Participant has confirmation of acute myeloid leukemia (AML) by World HealthOrganization (WHO) criteria
• Participant is deemed by the investigator to be an appropriate candidate foroutpatient ramp-up of venetoclax
• Participant is not eligible to receive treatment with standard cytarabine andanthracycline induction regimens
• Participant has not received prior treatment for AML (treatment naïve) with theexception of hydroxyurea
• Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening
• Participant can have progressed from myelodysplastic syndrome (MDS) or be consideredto have secondary AML and could have been treated with growth factors or other agentswith the exception of hypomethylating agents
• Participant has adequate kidney, liver, and hematology laboratory values as detailedin the protocol
• Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3

Exclusion Criteria: Has a history of the following conditions:

• Acute promyelocytic leukemia
• Known active central nervous system involvement with AML
• Positive for HIV (HIV testing is not required)
• Positive for hepatitis B or C infection with the exception of those with anundetectable viral load within 3 months
• Cardiovascular disability status of New York Heart Association Class > 2
• Chronic respiratory disease that requires continuous oxygen or any other medicalcondition that in the opinion of the investigator would adversely affect his/herparticipating in this study
• Malabsorption syndrome or other condition that precludes enteral route ofadministration Has a history of other malignancies within 2 years prior to study entry, with the exceptionof:
• Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ ofbreast
• Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
• Previous malignancy confined and surgically resected (or treated with othermodalities) with curative intent