Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma

Lymphoma Clinical Trial

Official title: Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)

Status Completed

Clinical Trial Summary

The purpose of this study is to obtain safety and efficacy data using tositumomab or Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Clinical Trial Description

New treatment modalities are needed for diffuse large cell B cell non-Hodgkin's lymphoma (DLCL). Only 35-40% of patients with DLCL are curable with standard therapy. Therefore, approximately 60-65% of DLCL patients subsequently need salvage therapy. Salvage regimens (e.g. ESHAP, DHAP, (R)-ICE, etc) are very toxic, especially in elderly patients, and have a response rate (RR) of only 45-60% in these patients. The median survival from the time of relapse is less than one year and only a small fraction of such patients benefit from autologous stem cell transplant (ASCT).

There is a lack of efficacious treatment options for patients with relapsed/refractory DLCL who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT00490009
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Completion date: February 2013