Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura
RATIONALE: Rituximab and prednisone may increase the number of platelets in patients with immune thrombocytopenic purpura.
PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with prednisone works as first-line therapy in treating patients with immune thrombocytopenic purpura.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura|
- Failure-free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Time to platelet recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Duration of platelet recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Effect of treatment on prevention of spontaneous bleeding events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Experimental: PRED & RITUX||
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
Other Name: RituxanDrug: Prednisone
1mg/kg/d PO, taper to off by 8 weeks
- Determine the efficacy of rituximab, when administered with standard prednisone treatment, in maintaining a platelet count ≥ 50,000/mm³ at 6 months without further therapies (e.g., splenectomy or other salvage therapies) in patients with immune thrombocytopenic purpura.
- Determine the safety of this regimen in these patients.
- Determine the time to platelet recovery in patients treated with this regimen.
- Determine the duration of platelet recovery in patients treated with this regimen.
- Assess efficacy of this regimen in preventing spontaneous bleeding events in these patients.
- Determine the response in patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive rituximab IV on days 1, 8, 15, and 22 and oral prednisone once daily on days 1-14 followed by a taper to day 56. Treatment is administered in the absence of disease relapse or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 3 years.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Ruben A. Mesa, M.D.||Mayo Clinic|