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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
11 Sites
310 Participants
12 Years

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Scottsdale HH Cancer Transplant
Scottsdale, Arizona, 85258, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Cancer Center (University Hospitals UH Seidman Cancer Center Ireland Cancer Center)
Cleveland, Ohio, 44106, United States
Centennial Medical Center (TriStar BMT)
Nashville, Tennessee, 37203, United States
The University of TexasMD Anderson Cancer Center
San Antonio, Texas, 77030, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States

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