| Palifermin for the reduction of acute GVHD: a randomized, double-blind, placebo-controlled trial. | |
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MedLine Citation:
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PMID: 22327131 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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.Bone Marrow Transplantation advance online publication, 13 February 2012; doi:10.1038/bmt.2011.261. |
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Authors:
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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 |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-2-13 |
Journal Detail:
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Title: Bone marrow transplantation Volume: - ISSN: 1476-5365 ISO Abbreviation: - Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-2-13 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8702459 Medline TA: Bone Marrow Transplant Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Hematology and Stem Cell Transplant, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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