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

PHASE3CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

January 9, 2020

Primary Completion Date

September 11, 2023

Study Completion Date

June 26, 2024

Conditions
Graft Versus Host Disease (GVHD)
Interventions
BIOLOGICAL

Alpha-1 antitrypsin (AAT)

AAT is a lyophilized product for intravenous administration

DRUG

Placebo

Albumin solution administered intravenously

Trial Locations (25)

10065

MSKCC, New York

21287

Johns Hopkins Hospital, Baltimore

23298

Virginia Commonwealth Univ., Richmond

27705

Duke, Durham

28204

Levine Cancer Center, Charlotte

30342

Northside Hospital, Atlanta

32608

University of Florida, Gainesville

33612

Moffitt Cancer Center, Tampa

37232

Vanderbilt-Ingram Cancer Center, Nashville

43210

Ohio State Univ.Medical Center, Columbus

44124

Cleveland Clinic, Cleveland

46202

IU Hospital, Indianapolis

48201

Karmanos Cancer Center, Detroit

53226

Medical College of Wisconsin, Milwaukee

53705

University of Wisconsin, Madison

55455

University of Minnesota, Minneapolis

63110

Washington University, St Louis

66205

Univ. of Kansas Cancer Center, Westwood

77030

Center for Gene Therapy, Houston

MD Anderson Cancer Center, Houston

94305

Stanford University, Stanford

98109

Fred Hutchinson Clinic, Seattle

30322-1059

Emory University, Atlanta

02215

Dana Farber Cancer Institute, Boston

48109-0312

U-M Medical Center, Ann Arbor

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

CSL Behring

INDUSTRY