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Trial Summary


Protocol No.CTO-BMTCTN1705
StatusOPEN TO ACCRUAL
Principal InvestigatorFarag, Sherif
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined with Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant
DescriptionStudy CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Any graft or donor source or conditioning intensity is allowed.
  • Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication.
  • Cannot be receiving other drugs for the treatment of GVHD.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesAny Site
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu