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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 UniversityNew Orleans, Louisiana  70112-2282
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Stanford University Medical CenterStanford, California  94305-5408
University of Rochester Cancer CenterRochester, New York  14642
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Texas Oncology, P.A.Dallas, Texas  75246
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Sutter Cancer CenterSacramento, California  95816
Michigan State UniversityEast Lansing, Michigan  48824
Sidney Kimmel Cancer CenterSan Diego, California  92121
Rocky Mountain Cancer CenterDenver, Colorado  80218
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of VirginiaCharlottesville, Virginia  22908
University of California, San FranciscoSan Francisco, California  94143
Kaiser Permanente Medical CenterVallejo, California  94589
Roswell Park Cancer CenterBuffalo, New York  14263
M.D. Anderson Cancer CenterHouston, Texas  77030
University of Maryland Cancer CenterBaltimore, Maryland  21201
Georgetown University Medical CenterWashington, District of Columbia  20007
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
City of Hope Natioal Medical CenterDuarte, California  
UCSD Stem Cell LaboratoryLa Jolla, California  
Scripps Memorial HospitalLa Jolla, California  
Hoag HospitalNewport Beach, California  
Robert H. Lurie Cancer Center, Northwestern UniversityChicago, Illinois  
University of Iowa General HospitalIowa City, Iowa  
St. Louis University Medical CenterSt. Louis, Missouri  
The West Clinic, P.C.Memphis, Tennessee  
University of Texas Health Sciences CenterSan Antonio, Texas