An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Summary

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

Timeline

Start

2018-02-21

Primary completion

2020-05-12

Completion

2020-05-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper This study estimated incidences of aGvHD and was not statistically powered to assess differences among treatment arms. PMID 36519326 ↗

Publications

• Hudspeth M, Mori S, Nachbaur D, Perez-Simon JA, Stolzel F, Riches M, Wu W, Zhang P, Agarwal S, Yakoub-Agha I. A phase II, prospective, randomized, open-label study of defibrotide added to standard-of-care prophylaxis for the prevention of acute graft-versus-host disease after allogeneic hematopoietic cell transplantation. Haematologica. 2023 Apr 1;108(4):1026-1038. doi: 10.3324/haematol.2022.281471.

Drugs

Indications