Status:
COMPLETED
The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 steroi...
Eligibility Criteria
Inclusion
- Patient must have undergone HCT (donor cells from any source) with either a myeloablative or nonmyeloablative preparative regimen.
- Patient may be any age.
- 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
- Patients who are pregnant (positive urine or serum test) or nursing.
- Active infections which are unresponsive to antibiotics (\> 2 consecutive \[at least 24 hours apart\], positive blood cultures after initiation of treatment).
- Allergic or otherwise undesirable reaction to etanercept.
- 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.
- Use of etanercept for any other purpose.
- Noncompliance with medications.
- Grade II-IV GVHD (history of or at time of study entry).
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00726375
Start Date
May 1 2008
End Date
September 1 2014
Last Update
January 5 2016
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109