drugset / Trial / NCT00774202
Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP
Phase 2/3
Completed
17 enrolled
Weill Medical College of Cornell University
Biogen · collabGenentech, Inc. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |