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

This study has been completed.
Information provided by:
Biogen Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Condition Intervention Phase
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma Drug: rituximab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • overall response rate

Secondary Outcome Measures:
  • time to disease progression
  • progressive disease-free interval

Estimated Enrollment: 150
Study Start Date: April 1995

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00168740

  Show 31 Study Locations
Sponsors and Collaborators
Study Director: Antonio J. Grillo-Lopez, M.D. Biogen
  More Information

Publications: Identifier: NCT00168740     History of Changes
Other Study ID Numbers: IDEC-102-05
Study First Received: September 13, 2005
Last Updated: September 13, 2005

Keywords provided by Biogen:
B-cell lymphoma
anti-CD20 monoclonal antibody

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on August 18, 2017