A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
I. Determine 10-month relapse-free survival of patients with acute myeloid leukemia in
first complete remission treated with cilengitide as maintenance therapy.
I. Determine overall survival of patients treated with this drug. II. Determine the safety
and toxicity of this drug in these patients. III. Determine the biological activity of this
drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4
In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (DFS)
Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.
From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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