The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease
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|ClinicalTrials.gov Identifier: NCT00141713|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 13, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Graft-Versus-Host Disease||Drug: Etanercept||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||December 2006|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141713
|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|