Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.

Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 75,000/mm3 on two occasions at least 1 week apart within past month

Normal to increased numbers of megakaryocytes on bone marrow examination within past 6 months

Failed prior steroid therapy (i.e., unable to achieve sustained platelet count greater than 75,000/mm3)

No drug associated ITP

No B cell malignancies

No evidence of disseminated intravascular coagulation (DIC)

--Prior/Concurrent Therapy--

Endocrine therapy: Concurrent steroids allowed as long as platelet count is less than 75,000/mm3 and dose is not changed within past 2 weeks or during study

Other:

• No other concurrent medical therapy for immune thrombocytopenia purpura (ITP)
• At least 2 weeks since prior therapy for ITP (except steroids)
• At least 4 weeks since prior cyclosporine

--Patient Characteristics--

Performance status: ECOG 0-2

Life expectancy: At least 6 months

Renal: Creatinine no greater than 2.0 mg/dL

Cardiovascular: No congestive heart failure or symptomatic coronary insufficiency

Other:

• No clinically significant bleeding (i.e., other than mild mucosal bleeding or petechiae)
• No sepsis or fever
• No active infection requiring therapy
• No active chronic viral infection
• HIV negative
• No other concurrent or prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception