A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens
(arms) as the front-line treatment of elderly patients aged 70 years or older with newly
diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction
chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine,
and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall
survival. The study is designed to demonstrate an improvement in overall survival of Arm A
versus Arm C.

Inclusion Criteria:

- Newly diagnosed AML based on WHO (World Health Organization) 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 (Eastern Cooperative Oncology Group) performance status 0-2

- Adequate renal function

- Adequate liver function

- Able to swallow capsules

- Agree to practice effective contraception

- 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 preceding myelodysplastic
syndrome (MDS) or myeloproliferative disease (MPD)

- Known or suspected central nervous system (CNS) involvement by leukemia

- Uncontrolled intercurrent illness

- Known hypersensitivity to decitabine

- Known to be HIV-positive