Spots Global Cancer Trial Database for Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

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Trial Identification

Brief Title: Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

Official Title: Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

Study ID: NCT00283582

Conditions

Sarcoma

Interventions

rhTPO

Study Description

Brief Summary: Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.

Detailed Description: 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 rhTPO.