The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
NCT ID: NCT03805789
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
222 participants
INTERVENTIONAL
2019-03-27
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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AAT (low dose)
Open label. AAT is a lyophilized product for intravenous (IV) administration
AAT
AAT is a lyophilized product for IV administration.
AAT (medium dose)
Open label. AAT is a lyophilized product for IV administration
AAT
AAT is a lyophilized product for IV administration.
AAT (high dose)
Open label. AAT is a lyophilized product for IV administration
AAT
AAT is a lyophilized product for IV administration.
AAT (selected dose from open-label)
Double-blind. AAT is a lyophilized product for IV administration
AAT
AAT is a lyophilized product for IV administration.
Placebo
Albumin solution administered intravenously
Placebo
Albumin solution administered intravenously
Interventions
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AAT
AAT is a lyophilized product for IV administration.
Placebo
Albumin solution administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* • Planned myeloablative conditioning regimen.
* • Participants must have a related or unrelated donor as follows:
* \- Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing.
* \- Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
Exclusion Criteria
* • T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin \[ATG\], alemtuzumab) for GVHD prophylaxis.
* • Planned umbilical cord blood transplant.
* • Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
* • Planned haploidentical donor.
12 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Physician
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Valle de Hebron
Barcelona, , Spain
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
Johns Hopkins Hospital
St. Petersburg, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
The University of Texas-MD Anderson Cancer Center
San Antonio, Texas, United States
University of Utah Primary Children's Hospital
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Royal Brisbane and Women's Hospital
Herston, Queenland, Australia
Uniklinik Köln
Cologne, , Germany
University Hospital Catania
Calabria, Catania, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Calabria, , Italy
Anjo Kosei Hospital
Anjo-shi, , Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, , Japan
Hiroshima University Kasumi Campus
Hiroshima, , Japan
Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, , Japan
Nagoya University Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Hokkaido University Hospital
Sapporo, , Japan
INJE University Haeundae Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Marqués de Valdecilla University Hospital
Barcelona, , Spain
Salamanca University Hospital
Salamanca, , Spain
Ankara Abdurrahman Yurtaslan
Ankara, , Turkey (Türkiye)
Turgut Ozal Medicine Center
Battalgazi, , Turkey (Türkiye)
Countries
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Other Identifiers
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2018-000329-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511164-92-00
Identifier Type: CTIS
Identifier Source: secondary_id
CSL964_2001
Identifier Type: -
Identifier Source: org_study_id
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