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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

Recruiting
I'm interested

12 years and over
This study is NOT accepting healthy volunteers
Inclusion 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
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 (UCB) transplant

Biological: Alpha-1 antitrypsin (AAT), Biological: Placebo

Acute-graft-versus-host Disease

Trial Registration Coordinator - clinicaltrials@cslbehring.com
Phase 2/Phase 3
NCT03805789
See this study on ClinicalTrials.gov

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