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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
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