A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan
radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or
transformed B-cell non-Hodgkin's lymphoma.
OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8
immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive
ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2
years and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols.
up to 4.25 years
No
Mansoor N. Saleh, MD
Study Chair
University of Alabama at Birmingham
United States: Federal Government
CDR0000067697
NCT00005592
November 1999
November 2005
Name | Location |
---|---|
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |