Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT00042913
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2002