The primary objective of Part 1 this study is to evaluate 1-year survival rate of 3
dosing schedules in elderly patients with previously untreated or first relapsed AML
or previously treated MDS; the secondary objectives are to assess the number of
patients who have achieved a CR, CRp, PR or CRi or hematological improvement
and their corresponding durations, transfusion requirements, number of hospitalized
days and safety.
The primary objective of Part 2 of this study is to evaluate the rate of clinical benefit
response (CR, CRp, PR, or major HI) and the rate of complete response (CR or CRp)
in elderly patients with previously untreated AML and significant concomitant
medical illnesses defined as having a HCTCI of 2 or higher; the secondary objectives
are to assess response duration, transfusion requirements, number of hospitalized
days, overall survival, and safety.
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