NCT00486421

Rituximab and Prednisone as First-Line Therapy in Treating Patients With Immune Thrombocytopenic Purpura

A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Nonneoplastic Condition

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab	375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
DRUG	Prednisone	1mg/kg/d PO, taper to off by 8 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-05-01
• Completion: 2008-11-01
• First posted: 2007-06-14
• Last updated: 2014-10-17

Locations

1 site across 1 country: United States