A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia

Inclusion Criteria:

- Newly diagnosed AML based on WHO classification

- 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

- 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

- Having received any systemic anti-cancer therapy for AML or received treatment with
hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD

- Known central nervous system (CNS) involvement by leukemia

- Uncontrolled intercurrent illness including

- Known hypersensitivity to decitabine

- Known to be HIV-positive