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
1 other identifier
interventional
150
2 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedSeptember 15, 2005
September 1, 2005
September 13, 2005
September 13, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
Secondary Outcomes (2)
time to disease progression
progressive disease-free interval
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of relapsed, low-grade or follicular B-cell lymphoma
- CD20-positive lymphoma
- Progressive, measurable disease
- Sign informed consent
- weeks beyond standard therapy
- Good performance status
- Adequate hematologic, renal, and hepatic function
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (31)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Natioal Medical Center
Duarte, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
UCSD Stem Cell Laboratory
La Jolla, California, United States
Hoag Hospital
Newport Beach, California, United States
Sutter Cancer Center
Sacramento, California, United States
Sidney Kimmel Cancer Center
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Robert H. Lurie Cancer Center, Northwestern University
Chicago, Illinois, United States
University of Iowa General Hospital
Iowa City, Iowa, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Louisiana State University
Shreveport, Louisiana, United States
University of Maryland Cancer Center
Baltimore, Maryland, United States
Michigan State University
East Lansing, Michigan, United States
St. Louis University Medical Center
St Louis, Missouri, United States
Roswell Park Cancer Center
Buffalo, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The West Clinic, P.C.
Memphis, Tennessee, United States
Texas Oncology, P.A.
Dallas, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario, Canada
Related Publications (1)
McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
PMID: 9704735RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonio J. Grillo-Lopez, M.D.
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
April 1, 1995
Last Updated
September 15, 2005
Record last verified: 2005-09