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

September 13, 2005 updated by: Biogen

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

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 Overview

Status

Completed

Conditions

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

Intervention / Treatment

Drug: rituximab

Study Type

Interventional

Enrollment

150

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Ottawa, Ontario, Canada
    - Ottawa General Hospital
  - Toronto, Ontario, Canada
    - Toronto-Sunnybrook Regional Cancer Center
United States
- Arkansas
  - Little Rock, Arkansas, United States
    - University of Arkansas for Medical Sciences
- California
  - Duarte, California, United States
    - City of Hope Natioal Medical Center
  - La Jolla, California, United States
    - Scripps Memorial Hospital
  - La Jolla, California, United States
    - UCSD Stem Cell Laboratory
  - Newport Beach, California, United States
    - Hoag Hospital
  - Sacramento, California, United States
    - Sutter Cancer Center
  - San Diego, California, United States
    - Sidney Kimmel Cancer Center
  - San Francisco, California, United States
    - University of California, San Francisco
  - Stanford, California, United States
    - Stanford University Medical Center
  - Vallejo, California, United States
    - Kaiser Permanente Medical Center
- Colorado
  - Denver, Colorado, United States
    - Rocky Mountain Cancer Center
- District of Columbia
  - Washington, District of Columbia, United States
    - Georgetown University Medical Center
- Illinois
  - Chicago, Illinois, United States
    - Robert H. Lurie Cancer Center, Northwestern University
- Iowa
  - Iowa City, Iowa, United States
    - University of Iowa General Hospital
- Kentucky
  - Lexington, Kentucky, United States
    - University of Kentucky Medical Center
- Louisiana
  - Shreveport, Louisiana, United States
    - Louisiana State University
- Maryland
  - Baltimore, Maryland, United States
    - University of Maryland Cancer Center
- Michigan
  - East Lansing, Michigan, United States
    - Michigan State University
- Missouri
  - St. Louis, Missouri, United States
    - St. Louis University Medical Center
- New York
  - Buffalo, New York, United States
    - Roswell Park Cancer Center
  - Rochester, New York, United States
    - University of Rochester Cancer Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
    - Fox Chase Cancer Center
  - Pittsburgh, Pennsylvania, United States
    - University of Pittsburgh Medical Center
- Tennessee
  - Memphis, Tennessee, United States
    - The West Clinic, P.C.
- Texas
  - Dallas, Texas, United States
    - Texas Oncology, P.A.
  - Houston, Texas, United States
    - M.D. Anderson Cancer Center
  - San Antonio, Texas, United States
    - University of Texas Health Sciences Center
- Virginia
  - Charlottesville, Virginia, United States
    - University of Virginia
- Washington
  - Seattle, Washington, United States
    - Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
overall response rate

Secondary Outcome Measures

Outcome Measure
time to disease progression
progressive disease-free interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

Study Director: Antonio J. Grillo-Lopez, M.D., Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1995

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

IDEC-102-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.