A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease

Inclusion Criteria

• •Age \>18 years
• •Patients must have clinical evidence\* of steroid-refractory acute Graft vs Host Disease (any organ) defined as one of the following:
• •* No change or progression in the stage of skin GvHD after at least 1 week of 2mg/kg/day methylprednisolone (or po equivalent)
• •* lack of response of visceral (liver, GI) GvHD despite treatment with 2mg/kg/day methylprednisolone for at least 72h.
• •* progression of visceral GvHD despite treatment with 2mg/kg/day methylprednisolone for at least 48h
• •* visceral GvHD progressing to stage 4 after 24h of 2mg/kg/d methylprednisolone
• •* Patients with protracted acute GvHD who have not responded to at least 0.5mg/kg/d of prednisone are considered eligible.
• •Ability to understand and the willingness to sign a written informed consent document.
• •\* As GvHD is a clinical diagnosis, and patients will have already been initiated on steroid therapy at the discretion of the attending physician, tissue confirmation of refractory GvHD by biopsy is not required for entry to this study. It is anticipated that most, but not all, patients will have undergone tissue confirmation of the initial diagnosis of GvHD; however lack of tissue confirmation for this clinical syndrome is not exclusionary.