Acute-graft-versus-host Disease

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
NCT03805789 | Phase 2 | Interventional

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).

Trial Information
24 Sites
310 Participants
Recruiting
12 Years

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SUBMIT
HonorHealth Scottsdale Shea Medical Center
Scottsdale,Arizona,United States,85258
Johns Hopkins Hospital
Saint Petersburg,Florida,United States,33701
Emory University
Atlanta,Georgia,United States,30322
University of Kansas Cancer Center
Westwood,Kansas,United States,66205
Dana Farber Cancer Institute
Boston,Massachusetts,United States,02215
University of Michigan Medical Center
Ann Arbor,Michigan,United States,48109
Duke University Medical Center
Durham,North Carolina,United States,27705
University Hospital Cleveland Medical Center
Cleveland,Ohio,United States,44106
The University of TexasMD Anderson Cancer Center
San Antonio,Texas,United States,77030
University of Virginia Health System
Charlottesville,Virginia,United States,22903
Fred Hutchinson Cancer Research Center
Seattle,Washington,United States,98109
Royal Brisbane and Women's Hospital
Herston,Australia,4029
Uniklinik Kln, lnnere Mediz
Köln,Germany,50937
University Hospital Catania
Calabria,Italy,95123
Grande Ospedale Metropolitano BianchiMelacrinoMorelli
Calabria,Italy,89133
INJE University Haeundae Paik Hospital
Busan,Korea, Republic of,48108
Pusan National University Hospital
Busan,Korea, Republic of,49241
Gachon University Gil Medical Center
Incheon,Korea, Republic of,21565
Seoul National University Hospital
Seoul,Korea, Republic of,03080
Hospital Universitario Valle de Hebron
Barcelona,Spain,08035
Marqus de Valdecilla University Hospital
Barcelona,Spain,39008
Salamanca University Hospital
Salamanca,Spain,37007
Ankara Abdurrahman Yurtaslan
Ankara,Turkey,06200
Turgut Ozal Medicine Center
Battalgazi,Turkey,44280

Study Eligibility Criteria

  • Male or female subjects, ≥12 years of age (≥ 18 years of age for subjects at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms
  • Planned myeloablative conditioning regimen
  • Prior autologous or allogeneic HCT
  • 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 (UCB) transplant

Additional Studies

Additional studies can be found at ClinicalTrials.gov