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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
Trial Status: active
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).
Inclusion Criteria
Male or female participants, >=12 years of age (>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
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
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 transplant.
Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
Planned haploidentical donor.
Additional locations may be listed on ClinicalTrials.gov for NCT03805789.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Utah
Salt Lake City
Primary Children's Hospital
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium