Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura
|ClinicalTrials.gov Identifier: NCT00486421|
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : October 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonneoplastic Condition||Biological: Rituximab Drug: Prednisone||Early Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||November 2008|
|Experimental: PRED & RITUX||
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
Other Name: Rituxan
1mg/kg/d PO, taper to off by 8 weeks
- Failure-free survival at 6 months [ Time Frame: 6 months ]
- Time to platelet recovery [ Time Frame: 1 year ]
- Duration of platelet recovery [ Time Frame: 1 year ]
- Effect of treatment on prevention of spontaneous bleeding events [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486421
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Ruben A. Mesa, M.D.||Mayo Clinic|