The primary objective of the study was to determine the feasibility of administering VSLI to relapsed or refractory AML patients having failed, refused or not a candidate for at least one chemotherapy salvage regimen. Feasibility was defined as at least four of the first 10 patients able to complete two cycles to allow the study to continue. Secondary objectives included the hematologic improvement rate of VSLI in this patient population, the response rate (CR, CRi, partial remission (PR), and morphologic leukemia-free state (MLFS)) and overall survival of patients treated with VSLI.

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