NCT00042913

Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	epratuzumab

Timeline

• Start date: 2002-05-01
• First posted: 2003-01-27
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States