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The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
Sponsor: CSL Behring
Summary
This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).
Official title: A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft-versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2019-03-27
Completion Date
2026-03-31
Last Updated
2025-11-04
Healthy Volunteers
No
Conditions
Interventions
AAT
AAT is a lyophilized product for IV administration.
Placebo
Albumin solution administered intravenously
Locations (34)
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
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario Valle de Hebron
Barcelona, Spain
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)