The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host disease (GVHD) can effectively treat and prevent progression of the disease without using high dose steroids.
GVHD is a common complication following a bone marrow transplant from another donor. GVHD occurs after transplant, when the donor's blood cells (called lymphocytes) recognize parts of your body, such as the skin, as foreign. A certain chemical, called Tumor Necrosis Factor, or TNF, also causes damage to the skin. The main effect on the skin is a red rash, when the skin GVHD is mild, but in more severe forms the skin can blister.
We have been studying GVHD at the University of Michigan for the past decade. We know that high levels of TNF makes GVHD worse. Our research has shown that adding an anti-TNF drug (called etanercept or Enbrel®) to the standard GVHD treatment of high dose steroids leads to improvement in the GVHD in twice as many patients compared to when steroids alone are used. It is now standard practice at the University of Michigan and many other centers to treat GVHD with both steroids and etanercept.
The management of early skin GVHD for most patients involves treatment with steroids, given both as a cream and by either the mouth (in pills) or IV. Early skin GVHD is also called grade I GVHD, which means the skin rash covers less than half of the body. Steroid treatment can be effective; however, it also causes many complications such as an increased risk of infection, weight gain, stomach ulcers, muscle weakness and bone damage, among many others. We have developed this study to test whether starting treatment with etanercept and steroid creams alone can treat the GVHD without requiring the use of high dose steroids. The goal is to avoid the complications that come with high dose oral or IV steroid treatment. The high dose steroid treatment would only begin if your GVHD got worse.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Etanercept (Enbrel) as Sole Treatment for Grade I Acute Graft Versus Host Disease|
- To determine with statistical certainty that treatment with etanercept alone for Grade I (stage 1-2 skin only) acute GVHD will reduce the percentage of patients who progress within 28 days of initiation of etanercept treatment, from 58% to 38%. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Estimate proportion patients in complete remission four weeks survival, never require additional therapy four weeks after the last dose of etanercept. Estimate the proportion of patients who respond to etanercept [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
a maximum of 8 SQ doses of 'Etanercept (Enbrel)at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Drug: Etanercept (Enbrel)
Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections.
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Sung Choi, MD||The University of Michigan Comprehensive Cancer Center|