Spots Global Cancer Trial Database for Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

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)

Study ID: NCT00022685

Conditions

Lymphoma

Interventions

epratuzumab

Study Description

Brief Summary: 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.

Detailed Description: 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.