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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
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

TerminatedPhase 2, Phase 3

Sponsor: CSL Behring

Conditions: Acute-graft-versus-host Disease

Interventions: AAT, Placebo

Countries: United States, Australia, Germany, Italy, Japan, South Korea, Spain, Turkey (Türkiye)

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). This study consisted of two parts. In Part 1, the dose of Alpha1-Proteinase Inhibitor (AAT) to be used in Part 2 was identified based on safety and pharmacokinetic data. The selected dose was subsequently evaluated in Part 2, where the primary objective was to assess its efficacy in preventing aGVHD following HCT.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (34)
  • Scottsdale, Arizona, United States
  • St. Petersburg, Florida, United States
  • Atlanta, Georgia, United States
  • Westwood, Kansas, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Charlottesville, Virginia, United States
  • Seattle, Washington, United States
  • Herston, Queenland, Australia
  • Cologne, Germany
  • Calabria, Catania, Italy
  • Calabria, Italy
  • Anjo-shi, Japan
  • Bunkyō City, Japan
  • Hiroshima, Japan
  • Nagoya, Japan
  • Nagoya, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Osaka, Japan
  • Sapporo, Japan
  • Busan, South Korea
  • Busan, South Korea
  • Incheon, South Korea
  • Seoul, South Korea
  • Barcelona, Spain
  • + 4 more on CT.gov