Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

Inclusion Criteria:

   - Patients 12 years of age or older

   - Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation
   for any indication

   - Any graft or donor source or conditioning intensity

   - Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids

Exclusion Criteria:

   - Prior exogenous AAT exposure for GVHD prophylaxis

   - Relapsed, progressing, or persistent malignancy

   - de novo chronic GVHD or overlap syndrome developing before or present at the time of
   enrollment

   - Receiving other drugs for the treatment of GVHD

   - Receiving systemic CS for any indication within 7 days before the onset of acute GVHD