The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center