Lymphoma Clinical Trial
Official title:
A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
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.
;
Masking: Open Label, Primary Purpose: Treatment
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