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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00168740
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Idec:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00168740

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

Publications:
ClinicalTrials.gov Identifier: NCT00168740     History of Changes
Other Study ID Numbers: IDEC-102-05
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
rituximab
Rituxan
B-cell lymphoma
low-grade
follicular
anti-CD20 monoclonal antibody

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014