The Use of Etanercept (Enbrel) as Sole Treatment for Grade I Acute Graft Versus Host Disease

Inclusion Criteria:

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.

Exclusion Criteria:

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).