Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)

Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma

Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.

Inclusion Criteria:

• Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
• CD20-positive lymphoma
• Progressive, measurable disease
• Sign informed consent
• 3 weeks beyond standard therapy
• Good performance status
• Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

• Chronic lymphocytic leukemia
• Lesions greater than or equal to 10 cm in diameter
• CNS lymphoma
• AIDS-related lymphoma
• Pleural effusions or ascites secondary to lymphoma
• Active, opportunistic infection
• Serious nonmalignant disease
• Prior investigational therapies, including prior anti-CD20 therapy
• Recent major surgery