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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.
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TRANSPLANTATION
Phase 1/2 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. M. Ferrara
From the Cancer Center, University of Minnesota, Minneapolis; the Department of Pediatrics, Division of Hematology/Oncology and Blood and Marrow Transplantation, University of Minnesota, Minneapolis; the Department of Medicine, Division of Hematology/Oncology and Blood and Marrow Transplantation, University of Minnesota, Minneapolis; the Biostatistical Support Group, University of Minnesota, Minneapolis; the School of Public Health, Department of Biostatistics, University of Michigan, Ann Arbor; the Divisions of Hematology/Oncology, Department of Pediatrics, University of Michigan Medical School, Ann Arbor; the Divisions of Hematology/Oncology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor; and the University of Michigan Comprehensive Cancer Center, Ann Arbor.
Palifermin, a recombinant human keratinocyte growth factor, was tested for potential benefits on acute graft-versus-host disease (GVHD) and hematopoietic recovery in allogeneic hematopoietic stem cell transplantation (HSCT) recipients. This randomized, double-blind, placebo-controlled, dose-escalation study assessed the safety and tolerability of palifermin (n = 69) as compared with placebo (n = 31) in patients conditioned with cyclophosphamide and fractionated total-body irradiation (Cy/TBI) or busulfan and cyclophosphamide (Bu/Cy) and given methotrexate along with a calcineurin inhibitor (cyclosporine A, tacrolimus) for GVHD prophylaxis. All patients received 3 doses before conditioning and either 3 (cohort 1), 6 (cohort 2), or 9 (cohort 3) doses after HSCT. Palifermin doses were 40 µg/kg per day (cohort 1 only) or 60 µg/kg per 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 HSCTs but had no significant effect on engraftment, acute GVHD, or survival in this trial.
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