A Pilot Study of Rituximab in Combination With Corticosteroids for the Initial Treatment of Immune Thrombocytopenic Purpura
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure-free survival at 6 months
6 months
No
Ruben A. Mesa, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
CDR0000529883
NCT00486421
January 2007
November 2008
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |