Palifermin for the reduction of acute GVHD: A randomized, double-blind, placebo-controlled trial

M. H. Jagasia, R. Abonour, G. D. Long, B. J. Bolwell, G. G. Laport, T. B. Shore, S. Durrant, J. Szer, M. G. Chen, R. Lizambri, E. K. Waller

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1350-1355
Number of pages6
JournalBone Marrow Transplantation
Volume47
Issue number10
DOIs
StatePublished - Oct 1 2012

Keywords

  • GVHD
  • Hematopoietic cell transplantation
  • MTX
  • Palifermin

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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    Jagasia, M. H., Abonour, R., Long, G. D., Bolwell, B. J., Laport, G. G., Shore, T. B., Durrant, S., Szer, J., Chen, M. G., Lizambri, R., & Waller, E. K. (2012). Palifermin for the reduction of acute GVHD: A randomized, double-blind, placebo-controlled trial. Bone Marrow Transplantation, 47(10), 1350-1355. https://doi.org/10.1038/bmt.2011.261