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

Phase 3
Open (Enrolling)
Acute Graft Versus Host Disease

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Trial Information

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).

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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%.

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Sung Choi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2007.139



Start Date:

May 2008

Completion Date:

June 2015

Related Keywords:

  • Acute Graft Versus Host Disease
  • (GVHD)
  • Graft vs Host Disease



University of Michigan Ann Arbor, Michigan  48109-0624