Palifermin for the reduction of acute GVHD: a randomized, double-blind, placebo-controlled trial
| Autor: | Madan Jagasia, Mon-Gy Chen, R. Lizambri, Edmund K. Waller, Simon Durrant, Gwynn D. Long, Brian J. Bolwell, Jeff Szer, Ginna G. Laport, Tsiporah B. Shore, Rafat Abonour |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Fibroblast Growth Factor 7 Transplantation Conditioning Adolescent Placebo-controlled study Graft vs Host Disease Placebo Gastroenterology law.invention Double-Blind Method Randomized controlled trial immune system diseases law Internal medicine medicine Mucositis Humans Transplantation Homologous Adverse effect Stomatitis Transplantation business.industry Hematology Middle Aged medicine.disease Rash surgical procedures operative Palifermin Hematologic Neoplasms Anesthesia Acute Disease Female medicine.symptom business Immunosuppressive Agents Stem Cell Transplantation medicine.drug |
| Zdroj: | Bone Marrow Transplantation. 47:1350-1355 |
| ISSN: | 1476-5365 0268-3369 |
| Popis: | This prospective, randomized, double-blind, placebo-controlled study evaluated the efficacy of palifermin to reduce the incidence of severe (grade 3-4) acute GVHD after myeloablation and allo-SCT. Adults who received allo-SCT for hematologic malignancies received placebo or palifermin 60 μg/kg daily on three consecutive days before conditioning and a single dose of 180 μg/kg after conditioning, but often 1 or 2 days before allo-SCT. Subjects received MTX (plus CYA or tacrolimus) on days 1, 3, 6 and 11. Acute GVHD was evaluated once weekly and oral mucositis was evaluated daily. Subjects were randomly assigned to placebo (n=78) or palifermin (n=77). Conditioning included TBI in approximately half of the subjects (48% placebo, 51% palifermin). The primary efficacy end point, subject incidence of grade 3-4 acute GVHD, was similar between treatment groups (17% placebo, 16% palifermin). Grade 3-4 oral mucositis (73% placebo, 81% palifermin) and other secondary efficacy end points were similar between treatment groups. The most commonly reported treatment-related adverse events were skin/s.c. events such as rash, pruritus, and erythema. This exploratory study of acute GVHD after myeloablation and allo-SCT did not provide evidence of a treatment effect with this dosing regimen of palifermin. |
| Databáze: | OpenAIRE |
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