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Blood, 1 November 2006, Vol. 108, No. 9, pp. 3216-3222. Prepublished online as a Blood First Edition Paper on July 11, 2006; DOI 10.1182/blood-2006-04-017780. This Article Full Text (PDF) All Versions of this Article: blood-2006-04-017780v1 108/9/3216    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Blazar, B. R Articles by Ferrara, J. L Search for Related Content PubMed PubMed Citation Articles by Blazar, B. R Articles by Ferrara, J. L Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted April 19, 2006 Accepted June 27, 2006 A phase I/II randomized, placebo-control trial of Palifermin to prevent graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT) Bruce R Blazar*, Daniel J Weisdorf, Todd DeFor, Anne Goldman, Thomas Braun, Samuel Silver, and James L Ferrara Departments of Pediatrics, Division of Hematology/Oncology & Blood, University of Minnesota Cancer Center and Dept of Medicine, Divn of Hematology/Oncology & Blood & Marrow Transpl Univ of MN Cancer Center and Biostatistical Support Group Univ of MN Cancer Center & School of Public Health, Dept of Biostatistics Univ of MN School of Public Health, Dept of Biostatistics, Univ of Michigan Divisions of Hematology/Oncology Dept of Ped and Internal Med Univ of Michigan * Corresponding author; email: blaza001{at}tc.umn.edu. Palifermin, a recombinant human keratinocyte growth factor, was tested for potential benefits on acute GVHD and hematopoietic recovery in allogeneic HSCT recipients. This randomized, double-blind, placebo-controlled, dose-escalation study assessed the safety and tolerability of palifermin (n=69) as compared to placebo (n=31) in patients conditioned with cyclophosphamide/fractionated total-body irradiation (Cy/TBI) or busulfan/cyclophosphamide and given methotrexate along with a calcineurin inhibitor (cyclosporine A, tacrolimus) for GVHD prophylaxis. All patients received 3 doses pre-conditioning and either 3 (cohort 1), 6 (cohort 2), or 9 (cohort 3) doses after HSCT. Palifermin doses were 40 mcg/kg/day (cohort 1 only) or 60 mcg/kg/day (all cohorts). Six patients (placebo=2, palifermin=4), experienced a total of 11 dose-limiting toxicities (most often skin, respiratory, or oral mucositis). The most common adverse events included edema, infection, skin pain, or rash. Times to neutrophil and platelet engraftment were similar. No significant differences in acute GVHD incidence or severity, survival, or day 100 relapse rates were observed between groups. Palifermin was associated with reduced incidence and mean severity of mucositis in patients conditioned with Cy/TBI but not Bu/Cy. We conclude that palifermin was generally safe in allogeneic HSCT, but had no significant effect on engraftment, acute GVHD, or survival in this trial. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: Y. Zhang, E. Hexner, D. Frank, and S. G. Emerson CD4+ T Cells Generated De Novo from Donor Hemopoietic Stem Cells Mediate the Evolution from Acute to Chronic Graft-versus-Host Disease J. Immunol., September 1, 2007; 179(5): 3305 - 3314. [Abstract] [Full Text] [PDF] S. W. Rossi, L. T. Jeker, T. Ueno, S. Kuse, M. P. Keller, S. Zuklys, A. V. Gudkov, Y. Takahama, W. Krenger, B. R. Blazar, et al. Keratinocyte growth factor (KGF) enhances postnatal T-cell development via enhancements in proliferation and function of thymic epithelial cells Blood, May 1, 2007; 109(9): 3803 - 3811. [Abstract] [Full Text] [PDF]

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