The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
Terminated · Phase 2, Phase 3 · NCT03805789
Conditions: Acute-graft-versus-host Disease
At a glance
- Research payments reported, 2025
- $1.4M
- U.S. investigators named
- 12
- Sites paid
- 13
- Planned or actual enrollment
- 222
About the trial
- Sponsor
- CSL Behring
- Tested
- AAT (biological), Placebo (biological)
- Dates
- Started 2019-03-27; completion 2026-03-19
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-09-09. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Csl Behring reported $1.4M in research payments for this study in 2025 (211 payments).
Products named: Zemaira, Andembry
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Adrienne D. Briggs, M.D. Hematology & Oncology · Scottsdale, AZ
- Deepakbabu Chellapandian, M.D Pediatric Hematology & Oncology · Tampa, FL
- Edmund K. Waller, M.D. Hematology · Atlanta, GA
- Sunil Abhyankar, M.D. Hematology & Oncology · Westwood, KS
- John Koreth, MBBS DPHIL Hematology · Boston, MA
- Sarah M. Anand, M.D. Hematology · Ann Arbor, MI
- Mitchell Horwitz Infectious Disease · Durham, NC
- Molly M. Gallogly, MD Hematology & Oncology · Cleveland, OH
- Amin M. Alousi, M.D. Internal Medicine · Houston, TX
- Cesar Freytes, MD Hematology & Oncology · San Antonio, TX
- Leonid Volodin, M.D. Hematology & Oncology · Charlottesville, VA
- Masumi Ueda Oshima, M.D. Hematology & Oncology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Fred Hutchinson Cancer Center $499,664
- Dana-Farber PArtners Cancercare Inc. $276,093
- University of Michigan Health System, MI $170,608
- Emory University Hospital, GA $123,944
- All Children's Research Institute, Inc. $101,540
- Honor Health John C. Lincoln Medical Center, AZ $96,100
- University of Virginia Medical Center, VA $53,684
- Ut MD Anderson Cancer Center $32,250
- Kumc Research Institute, Inc. $29,839
- Duke University $17,096
- Uh Cleveland Medical Center, OH $13,193
- Western Institutional Review Board $641
- Sarah Cannon Research Institute $80
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.