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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
375mg/m2 IV weekly times 4 (days 1, 8, 15, 22)
1mg/kg/d PO, taper to off by 8 weeks
Mayo Clinic
Rochester, Minnesota, United States
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
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