Low-Grade or Follicular B-Cell Non-Hodgkin's LymphomaPhase 3NCT00168740

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

A Phase 3 study testing rituximab in people with Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma, run by Biogen at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
What is being tested?: rituximab
How many people: 150 participants
Where: 31 sitesin 2 countries
Study dates: Apr 1995to not given
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Serious nonmalignant disease
Prior investigational therapies, including prior anti-CD20 therapy
Recent major surgery

Trial locations and contacts

31 sites in 2 countries.

Country

City, postcode or hospital

31 sites in 2 countries

United States29 sites

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

Other trials in United States

Canada2 sites

Ottawa General Hospital
Ottawa, Ontario
Toronto-Sunnybrook Regional Cancer Center
Toronto, Ontario

Other trials in Canada

About this study

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

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.

Conditions: Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Being tested: rituximab
Keywords: rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody
Medical subject headings: Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rituximabDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

overall response rate

Secondary outcomes (2)

time to disease progression
progressive disease-free interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 1995?

First posted15 Sep 2005 (estimated)
Study startApr 1995

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low-Grade or Follicular B-Cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168740
Sponsor's protocol ID: IDEC-102-05
Status last verified: Sep 2005
First submitted: 13 Sep 2005
Last updated: 15 Sep 2005
Results posted: No

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.
PubMed 9704735