The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate of etanercept when administered with steroids for treatment of biopsy proven aGVHD.
at 1, 2, and 3 months
John E. Levine, MS MD
University of Michigan
United States: Food and Drug Administration
|The University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109|