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

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Trial Identification

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

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 ID: NCT00042913

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: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.

Detailed Description: 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.