The primary objective of this study is to evaluate the 1-year survival rate of three dosing schedules of sapacitabine in elderly patients with previously untreated or first relapsed acute myeloid leukemia (AML). Secondary objectives are to assess the number of patients who have achieved a complete remission (CR) or CR without blood count recovery (CRi), duration of CR or CRi, transfusion requirements, number of hospitalized days and safety.
The study uses a selection design with the objective of identifying a dosing schedule which produces a better one year survival rate in the event that all three dosing schedules are active. The trial will enroll a total of approximately 60 patients or approximately 20 patients in each arm. The study uses a Bayesian continuous monitoring rule to stop accrual in one or more arms of the study in the event that a dosing schedule does not appear to have a sufficient number of responses.
This study follows the encouraging anti-leukemic activity observed in a Phase I trial of oral sapacitabine in patients with advanced leukemias or myelodysplastic syndromes (MDS) in which previously treated patients with AML or MDS achieved CR or CR without platelet count recovery.