Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Inclusion Criteria:

Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
ECOG performance status 0-2
Adequate renal function
Adequate liver function
Able to swallow capsules
Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
Known central nervous system (CNS) involvement by leukemia
Uncontrolled intercurrent illness including
Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
Known to be HIV-positive