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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Immune Thrombocytopenic Purpura
Interventions
DRUG

Rituxan, Cyclophosphamide, Vincristine, Prednisone

'Rituximab, Cyclophosphamide, Vincristine, Prednisone interventions are as follows: 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 infusions of C and V and oral P, and the following 3 rituximab infusions will be given on the same day as the 3 cycles of C, V, and P.

DRUG

Higher Dose of Rituximab

rituximab 750mg/m2 (twice the standard dose of 375mg/m2) will be given weekly for 4 weeks. Premedication and infusion rate escalation will be exactly the same as for standard dose rituximab. The additional dose will thus run at 400ml/hr.

Trial Locations (1)

10065

525 East 68th Street, New York

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Biogen

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER