Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
To evaluate the effectiveness of intravenous rhTPO vs. placebo as primary prophylaxis in
reducing the cumulative proportion of patients requiring platelet transfusion for severe
chemotherapy-induced thrombocytopenia (platelet count <15,000) during the first four study
cycles. To evaluate the severity and duration of thrombocytopenia and neutropenia associated
with rhTPO prophylaxis, the impact of rhTPO prophylaxis on health economics/cost
effectiveness, and patient quality of life. To assess the safety of multiple IV doses of
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
CBC with diff. at least three times a week and daily if platelet less than 50,000. Chemistry, coagulation, urinalysis performed at baseline and at end of cycle if necessary.
Saroj Vadhan-Raj, M.D.
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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