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Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Sponsor: CSL Behring
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
Official title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined With Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2020-01-09
Completion Date
2024-06-26
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
Alpha-1 antitrypsin (AAT)
AAT is a lyophilized product for intravenous administration
Placebo
Albumin solution administered intravenously
Locations (25)
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
IU Hospital
Indianapolis, Indiana, United States
Univ. of Kansas Cancer Center
Westwood, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
U-M Medical Center
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
MSKCC
New York, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
Duke
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State Univ.Medical Center
Columbus, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Center for Gene Therapy
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth Univ.
Richmond, Virginia, United States
Fred Hutchinson Clinic
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States