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


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This is a multicenter, randomized, Phase 3 study 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.

Who is eligible to participate?

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 - 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 the preceding MDS or MPD - Known or suspected central nervous system (CNS) involvement by leukemia - Uncontrolled intercurrent illness - Known hypersensitivity to decitabine - Known to be HIV-positive

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