dc.creator | Hudspeth, Michelle | es |
dc.creator | Mori, Shahram | es |
dc.creator | Nachbaur, David | es |
dc.creator | Pérez Simón, José Antonio | es |
dc.creator | Stölzel, Friedrich | es |
dc.creator | Riches, Marcie | es |
dc.creator | Wu, Wendy | es |
dc.creator | Zhang, Peixin | es |
dc.creator | Agarwal, Shirali | es |
dc.creator | Yakoub-Agha, Ibrahim | es |
dc.date.accessioned | 2024-04-26T13:01:37Z | |
dc.date.available | 2024-04-26T13:01:37Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Hudspeth, M., Mori, S., Nachbaur, D., Pérez Simón, J.A., Stölzel, F., Riches, M.,...,Yakoub-Agha, I. (2023). 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, 108 (4), 1026-1038. https://doi.org/10.3324/haematol.2022.281471. | |
dc.identifier.issn | 0390-6078 | es |
dc.identifier.uri | https://hdl.handle.net/11441/157216 | |
dc.description.abstract | Acute graft-versus-host disease (aGvHD) is a life-threatening complication typically occurring within 100 days after allogeneic hematopoietic cell transplantation (allo-HCT). This hypothesis-generating, phase II, prospective, open-label, randomized study (clinicaltrials gov. Identifier: NCT03339297) compared defibrotide added to standard-of-care (SOC) GvHD prophylaxis (defibrotide prophylaxis arm) versus SOC alone (SOC arm) to prevent aGvHD post-transplant. This study estimated incidences of aGvHD and was not statistically powered to assess differences among treatment arms. Patients were randomized 1:1 to defibrotide prophylaxis arm (n=79; median age 57 years; range, 2-69 years) or SOC arm (n=73; median age 56 years; range, 2-72 years). Patient demographics in the two arms were similar except for conditioning regimen type (myeloablative: defibrotide, 76% vs. SOC, 61%) and stem cell source for allo-HCT (bone marrow: defibrotide, 34% vs. SOC, 26%). In the intent-to-treat primary endpoint analysis, the cumulative incidence of grade B-D aGvHD at day 100 post-transplant was 38.4% in the defibrotide prophylaxis arm versus 47.1% in the SOC arm (difference: –8.8%, 90% confidence interval [CI]: –22.5 to 4.9). The difference noted at day 100 became more pronounced in a subgroup analysis of patients who received antithymocyte globulin (defibrotide: 30.4%, SOC: 47.6%; difference: –17.2%; 90% CI: –41.8 to 7.5). Overall survival rates at day 180 post-transplant were similar between arms, as were the rates of serious treatment-emergent adverse events (defibrotide: 42%, SOC: 44%). While the observed differences in endpoints between the two arms were not substantial, these results suggest defibrotide prophylaxis may add a benefit to currently available SOC to prevent aGvHD following allo-HCT without adding significant toxicities. | es |
dc.format | application/pdf | es |
dc.format.extent | 13 p. | es |
dc.language.iso | eng | es |
dc.publisher | Ferrata Storti Foundation | es |
dc.relation.ispartof | Haematologica, 108 (4), 1026-1038. | |
dc.rights | Atribución-NoComercial 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.title | 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 | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.contributor.affiliation | Instituto de Biomedicina de Sevilla (IBIS) | es |
dc.relation.publisherversion | https://haematologica.org/article/view/haematol.2022.281471 | es |
dc.identifier.doi | 10.3324/haematol.2022.281471 | es |
dc.journaltitle | Haematologica | es |
dc.publication.volumen | 108 | es |
dc.publication.issue | 4 | es |
dc.publication.initialPage | 1026 | es |
dc.publication.endPage | 1038 | es |