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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, multi-center, placebo‑controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).

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
  • Planned umbilical cord blood (UCB) transplant

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Jack Erie Wilson
Phone: 317-278-7866

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Utah

Salt Lake City
Primary Children's Hospital
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase II/III

Trial Type Prevention

Lead Organization
CSL Behring

  • Primary ID CSL964_2001
  • Secondary IDs NCI-2019-03310, 2018-000329-29
  • Clinicaltrials.gov ID NCT03805789