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

NCT ID: NCT00168740

Last Updated: 2005-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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rituximab Rituxan B-cell lymphoma low-grade follicular anti-CD20 monoclonal antibody

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rituximab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Principal Investigators

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Antonio J. Grillo-Lopez, M.D.

Role: STUDY_DIRECTOR

Biogen

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

City of Hope Natioal Medical Center

Duarte, California, United States

Site Status

Scripps Memorial Hospital

La Jolla, California, United States

Site Status

UCSD Stem Cell Laboratory

La Jolla, California, United States

Site Status

Hoag Hospital

Newport Beach, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Sidney Kimmel Cancer Center

San Diego, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

Kaiser Permanente Medical Center

Vallejo, California, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Robert H. Lurie Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

University of Iowa General Hospital

Iowa City, Iowa, United States

Site Status

University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Louisiana State University

Shreveport, Louisiana, United States

Site Status

University of Maryland Cancer Center

Baltimore, Maryland, United States

Site Status

Michigan State University

East Lansing, Michigan, United States

Site Status

St. Louis University Medical Center

St Louis, Missouri, United States

Site Status

Roswell Park Cancer Center

Buffalo, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

The West Clinic, P.C.

Memphis, Tennessee, United States

Site Status

Texas Oncology, P.A.

Dallas, Texas, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Texas Health Sciences Center

San Antonio, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Ottawa General Hospital

Ottawa, Ontario, Canada

Site Status

Toronto-Sunnybrook Regional Cancer Center

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type RESULT
PMID: 9704735 (View on PubMed)

Other Identifiers

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IDEC-102-05

Identifier Type: -

Identifier Source: org_study_id