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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
OBJECTIVES: * Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma. * Confirm the convenient administration of this drug in this patient population. * Determine the efficacy of this drug in terms of objective response rate in these patients. * Determine the duration of response and time to progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22. Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years. PROJECTED ACCRUAL: Approximately 30-100 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
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