- 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
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
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Scottsdale HH Cancer Transplant
Scottsdale,Arizona,United States,85258
Emory University
Atlanta,Georgia,United States,30322
University of Kansas Cancer Center
Westwood,Kansas,United States,66205
University of Michigan
Ann Arbor,Michigan,United States,48109
Duke University Medical Center
Durham,North Carolina,United States,27710
Cleveland Cancer Center (University Hospitals UH Seidman Cancer Center Ireland Cancer Center)
Cleveland,Ohio,United States,44106
Centennial Medical Center (TriStar BMT)
Nashville,Tennessee,United States,37203
The University of TexasMD Anderson Cancer Center
San Antonio,Texas,United States,77030
Methodist Hospital
San Antonio,Texas,United States,78229
Primary Children's Hospital
Salt Lake City,Utah,United States,84113
Seattle Cancer Care Alliance
Seattle,Washington,United States,98109
Royal Brisbane and Women's Hospital
Herston,Australia,4029
University Essen
Essen,Germany,45147
Uniklinik Kln, lnnere Mediz
Köln,Germany,50937
Complejo Hospitalario de Navarra
Pamplona,Spain,31008
Hospital Universitario Vall d
Barcelona,Spain,08035
Hospital Regional Universitario de Malaga
Málaga,Spain,29010
Universitario de Salamanca
Salamanca,Spain,37007
Hospital Universitario Marqus
Santander,Spain,M20 4BX
The Christie NHS Foundation
Manchester,United Kingdom
Study Eligibility Criteria
- 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