Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
NCT ID: NCT04167514
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2020-01-09
2024-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AAT
Alpha-1 antitrypsin (AAT) is a lyophilized powder for intravenous administration
Alpha-1 antitrypsin (AAT)
AAT is a lyophilized product for intravenous administration
Placebo
Albumin solution administered intravenously
Placebo
Albumin solution administered intravenously
Interventions
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Alpha-1 antitrypsin (AAT)
AAT is a lyophilized product for intravenous administration
Placebo
Albumin solution administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BMT CTN Protocol 1705
Identifier Type: OTHER
Identifier Source: secondary_id
CSL964_5001 / BMT CTN 1705
Identifier Type: -
Identifier Source: org_study_id
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