Journal article
Palifermin for the reduction of acute GVHD: A randomized, double-blind, placebo-controlled trial
MH Jagasia, R Abonour, GD Long, BJ Bolwell, GG Laport, TB Shore, S Durrant, J Szer, MG Chen, R Lizambri, EK Waller
Bone Marrow Transplantation | NATURE PUBLISHING GROUP | Published : 2012
DOI: 10.1038/bmt.2011.261
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 ..
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Funding Acknowledgements
This study was supported by research funding from Amgen Inc. Jonathan Latham of PharmaScribe, LLC received funding from Amgen Inc. to provide assistance with the preparation of the manuscript. Xuesong Guan of Amgen Inc. provided assistance with statistical analyses. The NCT00964899 study investigators were as follows (listed alphabetically): Rafat Abonour, Gorgun Akpek, Carlos Bachier, Brian Bolwell, Simon Durrant, Steven Goldstein, Richard Herrmann, David Hurd, Madan Jagasia, Ginna Laport, Ian Lewis, Gwynn Long, Kenneth F Mangan, Philip McCarthy, John M McCarty, Shin Mineishi, Han Myint, Scott D Rowley, Tsiporah Shore, Ricardo Spielberger, Roger Strair, Jeff Szer and Edmund K Waller.