Clinical trial NCT00168740: Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
Keywords: rituximab
Rituxan
B-cell lymphoma
low-grade
follicular
anti-CD20 monoclonal antibody
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: overall response rate
Secondary outcomes:
measure: time to disease progression
measure: progressive disease-free interval
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Duarte
country: United States
facility: City of Hope Natioal Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: La Jolla
country: United States
facility: UCSD Stem Cell Laboratory
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Diego
country: United States
facility: Sidney Kimmel Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Robert H. Lurie Cancer Center, Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa General Hospital
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Cancer Center
state: Maryland
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: St. Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic, P.C.
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Regional Cancer Center
state: Ontario
Study officials:
affiliation: Biogen
name: Antonio J. Grillo-Lopez, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.