The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
Information source: University of Michigan Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Graft Versus Host Disease
Intervention: Etanercept (Enbrel) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: University of Michigan Cancer Center
Official(s) and/or principal investigator(s):
Sung Choi, MD, Principal Investigator, Affiliation: The University of Michigan Comprehensive Cancer Center
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.
Official title: The Use of Etanercept (Enbrel) as Sole Treatment for Grade I Acute Graft Versus Host Disease
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment
Secondary outcome: The Number of Patients in Complete Remission (CR) at Four Weeks.
Minimum age: N/A.
Maximum age: N/A.
1. Patient must have undergone HCT (donor cells from any source) with either a
myeloablative or nonmyeloablative preparative regimen.
2. Patient may be any age.
3. Patient must have biopsy-proven Grade I acute GVHD (Appendix A). Biopsy report does
not have to be back from Pathology prior to enrollment. Patients whose biopsy for
GVHD identifies pathology inconsistent with GVHD will be removed from the study and
replaced. However, because GVHD is a clinical diagnosis, biopsies which are
non-diagnostic or do not show a clear non-GVHD etiology will not be cause to remove
the patient from the study.
1. Patients who are pregnant (positive urine or serum test) or nursing.
2. Active infections which are unresponsive to antibiotics (> 2 consecutive [at least 24
hours apart], positive blood cultures after initiation of treatment).
3. Allergic or otherwise undesirable reaction to etanercept.
4. Use of any oral or intravenous steroids at any previous time for GVHD treatment.
Prior use of steroid therapy (i. e. hydrocortisone) as pre-medication for transfusions
is permissible. Prior use of topical steroids is allowed.
5. Use of etanercept for any other purpose.
6. Noncompliance with medications.
7. Grade II-IV GVHD (history of or at time of study entry).
Locations and Contacts
University of Michigan, Ann Arbor, Michigan 48109, United States
Starting date: May 2008
Last updated: May 14, 2015