search
Back to results

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

Primary Purpose

Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rituximab
Sponsored by
Biogen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma focused on measuring rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • City of Hope Natioal Medical Center
  • Scripps Memorial Hospital
  • UCSD Stem Cell Laboratory
  • Hoag Hospital
  • Sutter Cancer Center
  • Sidney Kimmel Cancer Center
  • University of California, San Francisco
  • Stanford University Medical Center
  • Kaiser Permanente Medical Center
  • Rocky Mountain Cancer Center
  • Georgetown University Medical Center
  • Robert H. Lurie Cancer Center, Northwestern University
  • University of Iowa General Hospital
  • University of Kentucky Medical Center
  • Louisiana State University
  • University of Maryland Cancer Center
  • Michigan State University
  • St. Louis University Medical Center
  • Roswell Park Cancer Center
  • University of Rochester Cancer Center
  • Fox Chase Cancer Center
  • University of Pittsburgh Medical Center
  • The West Clinic, P.C.
  • Texas Oncology, P.A.
  • M.D. Anderson Cancer Center
  • University of Texas Health Sciences Center
  • University of Virginia
  • Fred Hutchinson Cancer Research Center
  • Ottawa General Hospital
  • Toronto-Sunnybrook Regional Cancer Center

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

time to disease progression
progressive disease-free interval

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Biogen
search

1. Study Identification

Unique Protocol Identification Number
NCT00168740
Brief Title
Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Keywords
rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
overall response rate
Secondary Outcome Measure Information:
Title
time to disease progression
Title
progressive disease-free interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio J. Grillo-Lopez, M.D.
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
City of Hope Natioal Medical Center
City
Duarte
State/Province
California
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
Country
United States
Facility Name
UCSD Stem Cell Laboratory
City
La Jolla
State/Province
California
Country
United States
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Sidney Kimmel Cancer Center
City
San Diego
State/Province
California
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Vallejo
State/Province
California
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Robert H. Lurie Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa General Hospital
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
University of Maryland Cancer Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
St. Louis University Medical Center
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
The West Clinic, P.C.
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology, P.A.
City
Dallas
State/Province
Texas
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto-Sunnybrook Regional Cancer Center
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
9704735
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs