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

Nonneoplastic Condition Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nonneoplastic Condition
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

• NCT number: NCT00486421
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 0
• Start date: January 2007
• Completion date: November 2008