Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Treatments:
Rituximab
Criteria
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