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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Collaborators: Blood and Marrow Transplant Clinical Trials Network; National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Alpha 1-Antitrypsin; Protease Inhibitors; Protein C Inhibitor

Criteria

Inclusion Criteria:

• Patients 18 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