drugset / Trial / NCT00774202

Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP

NCT00774202

RandomizedParallel-groupSingle-blindTreatment

Summary

This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups according to their initial response to Rituxan.

Timeline

Start
2003-11
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Prednisone Other / unclassified 100 mg Oral
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 750 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous