Trial | NCT00168740  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rituximab ...

  • Study Participants

    150
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.
Study Started
Apr 30
1995
Last Update
Sep 15
2005
Estimate

Drug 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
No Results Posted