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

Phase 3
Completed
Conditions
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Registration Number
NCT00168740
Lead Sponsor
Biogen
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
overall response rate
Secondary Outcome Measures
NameTimeMethod
time to disease progression
progressive disease-free interval

Trial Locations

Locations (31)

Hoag Hospital

πŸ‡ΊπŸ‡Έ

Newport Beach, California, United States

Fox Chase Cancer Center

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Robert H. Lurie Cancer Center, Northwestern University

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

M.D. Anderson Cancer Center

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

University of Arkansas for Medical Sciences

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

UCSD Stem Cell Laboratory

πŸ‡ΊπŸ‡Έ

La Jolla, California, United States

City of Hope Natioal Medical Center

πŸ‡ΊπŸ‡Έ

Duarte, California, United States

Roswell Park Cancer Center

πŸ‡ΊπŸ‡Έ

Buffalo, New York, United States

Kaiser Permanente Medical Center

πŸ‡ΊπŸ‡Έ

Vallejo, California, United States

Stanford University Medical Center

πŸ‡ΊπŸ‡Έ

Stanford, California, United States

Louisiana State University

πŸ‡ΊπŸ‡Έ

Shreveport, Louisiana, United States

University of Rochester Cancer Center

πŸ‡ΊπŸ‡Έ

Rochester, New York, United States

The West Clinic, P.C.

πŸ‡ΊπŸ‡Έ

Memphis, Tennessee, United States

Michigan State University

πŸ‡ΊπŸ‡Έ

East Lansing, Michigan, United States

Georgetown University Medical Center

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

St. Louis University Medical Center

πŸ‡ΊπŸ‡Έ

St. Louis, Missouri, United States

University of Maryland Cancer Center

πŸ‡ΊπŸ‡Έ

Baltimore, Maryland, United States

Toronto-Sunnybrook Regional Cancer Center

πŸ‡¨πŸ‡¦

Toronto, Ontario, Canada

Sidney Kimmel Cancer Center

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

University of Texas Health Sciences Center

πŸ‡ΊπŸ‡Έ

San Antonio, Texas, United States

University of California, San Francisco

πŸ‡ΊπŸ‡Έ

San Francisco, California, United States

University of Virginia

πŸ‡ΊπŸ‡Έ

Charlottesville, Virginia, United States

University of Iowa General Hospital

πŸ‡ΊπŸ‡Έ

Iowa City, Iowa, United States

Sutter Cancer Center

πŸ‡ΊπŸ‡Έ

Sacramento, California, United States

Scripps Memorial Hospital

πŸ‡ΊπŸ‡Έ

La Jolla, California, United States

Rocky Mountain Cancer Center

πŸ‡ΊπŸ‡Έ

Denver, Colorado, United States

Texas Oncology, P.A.

πŸ‡ΊπŸ‡Έ

Dallas, Texas, United States

Fred Hutchinson Cancer Research Center

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

University of Kentucky Medical Center

πŸ‡ΊπŸ‡Έ

Lexington, Kentucky, United States

University of Pittsburgh Medical Center

πŸ‡ΊπŸ‡Έ

Pittsburgh, Pennsylvania, United States

Ottawa General Hospital

πŸ‡¨πŸ‡¦

Ottawa, Ontario, Canada

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