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

Study Timeline

• Study Start: 1995-04
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-15
• Last Update Posted: 2005-09-15

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

Name	Time	Method
overall response rate

Secondary Outcome Measures

Name	Time	Method
time to disease progression
progressive disease-free interval

Trial Locations

Locations (31)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

City of Hope Natioal Medical Center; 🇺🇸 Duarte, California, United States

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

UCSD Stem Cell Laboratory; 🇺🇸 La Jolla, California, United States

Hoag Hospital; 🇺🇸 Newport Beach, California, United States

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

Sidney Kimmel Cancer Center; 🇺🇸 San Diego, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Vallejo, California, United States

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