The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease
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
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease|
- To evaluate the response rate of etanercept when administered with steroids for treatment of biopsy proven aGVHD. [ Time Frame: at 1, 2, and 3 months ] [ Designated as safety issue: Yes ]
- To analyze intracellular cytokine levels, lymphocyte phenotype and plasma cytokine levels in patients with aGVHD before and after treatment with etanercept and to correlate these laboratory endpoints with clinical outcomes during the trial. [ Time Frame: at 1, 2, and 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||December 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
etanercept treatment for GVHD
Patients enrolled on the study will receive etanercept at 0.4 mg/kg per dose up to a maximum of 25 mg per dose subcutaneously twice a week. Etanercept must be initiated within 72 hours of starting solumedrol.
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.
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||John E. Levine, MS MD||University of Michigan|