The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acute-graft-versus-host Disease

In brief

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).

Key facts

Study ID

NCT03805789

Run by

CSL Behring

People needed

222

Starts

2019-03-27

Expected to finish

2026-03-19

Last updated by the study team

2026-04-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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.

Where it is running

• HonorHealth Scottsdale Shea Medical Center — Scottsdale, Arizona, United States
• Johns Hopkins Hospital — St. Petersburg, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospital Cleveland Medical Center — Cleveland, Ohio, United States
• The University of Texas-MD Anderson Cancer Center — San Antonio, Texas, United States
• University of Utah Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Royal Brisbane and Women's Hospital — Herston, Queenland, Australia
• Uniklinik Köln — Cologne, Germany
• University Hospital Catania — Calabria, Catania, Italy
• Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli — Calabria, Italy
• Anjo Kosei Hospital — Anjo-shi, Japan
• Tokyo Metropolitan Komagome Hospital — Bunkyō City, Japan
• Hiroshima University Kasumi Campus — Hiroshima, Japan
• Aichi Medical Center Nagoya Daiichi Hospital — Nagoya, Japan
• Nagoya University Hospital — Nagoya, Japan
• Okayama University Hospital — Okayama, Japan
• Osaka International Cancer Institute — Osaka, Japan
• Osaka Metropolitan University Hospital — Osaka, Japan
• Hokkaido University Hospital — Sapporo, Japan

Full record on ClinicalTrials.gov

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