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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00168740

Collaborator

(none)

150

Enrollment

Locations

4.8

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma	Drug: rituximab	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 1995

Outcome Measures

Primary Outcome Measures

overall response rate []

Secondary Outcome Measures

time to disease progression []
progressive disease-free interval []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States
2	City of Hope Natioal Medical Center	Duarte	California	United States
3	Scripps Memorial Hospital	La Jolla	California	United States
4	UCSD Stem Cell Laboratory	La Jolla	California	United States
5	Hoag Hospital	Newport Beach	California	United States
6	Sutter Cancer Center	Sacramento	California	United States
7	Sidney Kimmel Cancer Center	San Diego	California	United States
8	University of California, San Francisco	San Francisco	California	United States
9	Stanford University Medical Center	Stanford	California	United States
10	Kaiser Permanente Medical Center	Vallejo	California	United States
11	Rocky Mountain Cancer Center	Denver	Colorado	United States
12	Georgetown University Medical Center	Washington	District of Columbia	United States
13	Robert H. Lurie Cancer Center, Northwestern University	Chicago	Illinois	United States
14	University of Iowa General Hospital	Iowa City	Iowa	United States
15	University of Kentucky Medical Center	Lexington	Kentucky	United States
16	Louisiana State University	Shreveport	Louisiana	United States
17	University of Maryland Cancer Center	Baltimore	Maryland	United States
18	Michigan State University	East Lansing	Michigan	United States
19	St. Louis University Medical Center	St. Louis	Missouri	United States
20	Roswell Park Cancer Center	Buffalo	New York	United States
21	University of Rochester Cancer Center	Rochester	New York	United States
22	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States
23	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States
24	The West Clinic, P.C.	Memphis	Tennessee	United States
25	Texas Oncology, P.A.	Dallas	Texas	United States
26	M.D. Anderson Cancer Center	Houston	Texas	United States
27	University of Texas Health Sciences Center	San Antonio	Texas	United States
28	University of Virginia	Charlottesville	Virginia	United States
29	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States
30	Ottawa General Hospital	Ottawa	Ontario	Canada
31	Toronto-Sunnybrook Regional Cancer Center	Toronto	Ontario	Canada