Study of Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP
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.
Immune Thrombocytopenic Purpura
Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone
Drug: Higher Dose of Rituximab
|Official Title:||A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment|
|Study Start Date:||November 2003|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Standard Dose of Rituxan and CVP
Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once weekly, the first infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP.
|Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone|
Active Comparator: Higher Dose of Rituximab
In this arm, Rituximab will be administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total). We will perform EKG monitor tracings before, during and after Rituxan infusions. This will be a single-lead tracing that will allow us to look at issues such as the Q-T interval.
|Drug: Higher Dose of Rituximab|
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|United States, New York|
|525 East 68th Street|
|New York, New York, United States, 10065|
|Principal Investigator:||James B Bussel, M.D.||Weill Medical College of Cornell University|