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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Principal Investigator

Antonio J. Grillo-Lopez, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Biogen Idec

Authority:

United States: Food and Drug Administration

Study ID:

IDEC-102-05

NCT ID:

NCT00168740

Start Date:

April 1995

Completion Date:

Related Keywords:

  • Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma
  • rituximab
  • Rituxan
  • B-cell lymphoma
  • low-grade
  • follicular
  • anti-CD20 monoclonal antibody
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
Louisiana State University New Orleans, Louisiana  70112-2282
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Stanford University Medical Center Stanford, California  94305-5408
University of Rochester Cancer Center Rochester, New York  14642
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Texas Oncology, P.A. Dallas, Texas  75246
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Sutter Cancer Center Sacramento, California  95816
Michigan State University East Lansing, Michigan  48824
Sidney Kimmel Cancer Center San Diego, California  92121
Rocky Mountain Cancer Center Denver, Colorado  80218
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
University of Virginia Charlottesville, Virginia  22908
University of California, San Francisco San Francisco, California  94143
Kaiser Permanente Medical Center Vallejo, California  94589
Roswell Park Cancer Center Buffalo, New York  14263
M.D. Anderson Cancer Center Houston, Texas  77030
University of Maryland Cancer Center Baltimore, Maryland  21201
Georgetown University Medical Center Washington, District of Columbia  20007
University of Kentucky Medical Center Lexington, Kentucky  40536-0093
City of Hope Natioal Medical Center Duarte, California  
UCSD Stem Cell Laboratory La Jolla, California  
Scripps Memorial Hospital La Jolla, California  
Hoag Hospital Newport Beach, California  
Robert H. Lurie Cancer Center, Northwestern University Chicago, Illinois  
University of Iowa General Hospital Iowa City, Iowa  
St. Louis University Medical Center St. Louis, Missouri  
The West Clinic, P.C. Memphis, Tennessee  
University of Texas Health Sciences Center San Antonio, Texas