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

Study CSL964\_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

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