Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma|
|Study Start Date:||May 2002|
- Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
- Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks.
- Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042913
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Christos E. Emmanouilides, MD||Jonsson Comprehensive Cancer Center|