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

Early Phase 1

Completed

• Conditions: Nonneoplastic Condition
• Interventions: Biological: Rituximab; Drug: Prednisone

• Registration Number: NCT00486421
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Primary Completion: 2008-05
• Study Completion: 2008-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRED & RITUX	Rituximab	-
PRED & RITUX	Prednisone	-

Primary Outcome Measures

Name	Time	Method
Failure-free survival at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Effect of treatment on prevention of spontaneous bleeding events	1 year
Time to platelet recovery	1 year
Duration of platelet recovery	1 year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States