Long-Term follow-up of a Phase I/II Randomized, Placebo-Controlled Trial of Palifermin to Prevent Graft-versus-Host Disease (GVHD) after Related Donor Allogeneic Hematopoietic Cell Transplantation (HCT)

John E. Levine, Bruce R. Blazar, Todd DeFor, James L M Ferrara, Daniel J. Weisdorf

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48 Scopus citations

Abstract

We previously conducted a randomized, double-blind, placebo-controlled study conducted from 2000 to 2003 of palifermin, a recombinant human keratinocyte growth factor, dosed from 240 μg/kg to 720 μg/kg, in 100 allogeneic hematopoietic stem cell transplantation (HCT) recipients. Treatment with palifermin showed beneficial effects on mucositis, but no significant effect on engraftment, acute graft-versus-host disease (GVHD), or early survival. In addition to the effect of palifermin on mucosa, other pleotrophic effects, including more rapid immune reconstitution, have been seen in experimental transplant models. Therefore, we investigated whether with longer follow-up we could detect additional differences between the palifermin-treated and placebo cohorts. We found no differences in CMV or invasive fungal infections, chronic GVHD, or long-term survival between cohorts. We conclude that the benefits of palifermin appear primarily to be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients.

Original languageEnglish (US)
Pages (from-to)1017-1021
Number of pages5
JournalBiology of Blood and Marrow Transplantation
Volume14
Issue number9
DOIs
StatePublished - Sep 2008

Bibliographical note

Funding Information:
The authors thank Pam James and Julie Formosa for excellent data collection and management. This work was supported by the following grants: National Institutes of Health Grants R01 HL073794, NIH P01 CA03952, and 2P30CA046592; Food and Drug Administration Grant FRD 020201; and Amgen.

Keywords

  • GVHD
  • Hematopoietic stem cell transplantation
  • Palifermin

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