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The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease

Graft-Versus-Host Disease Clinical Trial

Official title:
The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease

Clinical Trial Summary

Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to see if the effectiveness of standard therapy can be improved.

Partial Funding Source- FDA OOPD

Clinical Trial Description

The standard treatment for acute graft-versus-host disease is a combination of steroids and tacrolimus or cyclosporine. Previous work has shown that less than 50% of patients respond fully to GVHD. Without a good response, patients often have a prolonged treatment for this disease, often involving hospitalization and sometimes even death.

Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing damage to tissue. Etanercept (Enbrel) will be added to help improve the response to standard treatment for graft-versus-host disease (GVHD).

This is an experimental research project. It is not known whether the etanercept will actually improve the body's response to graft-versus-host disease. This treatment is meant to determine if etanercept will improve your response to treatment of GVHD. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00141713
Study type Interventional
Source University of Michigan Cancer Center
Contact
Status Completed
Phase Phase 2
Start date October 2003
Completion date December 2006
View Details
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