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document
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 ) . 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 microg/kg to 720 microg/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 .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
palifermin
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Intervention_Pharmacological
palifermin
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Intervention_Pharmacological
palifermin
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Intervention_Pharmacological
palifermin
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Intervention_Pharmacological
palifermin-treated
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Intervention_Control
placebo
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Intervention_Pharmacological
palifermin
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Outcome_Physical
mucositis
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Outcome_Physical
engraftment , acute graft-versus-host disease ( GVHD )
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Outcome_Mortality
early survival
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Outcome_Physical
mucosa , other pleotrophic effects , including more rapid immune reconstitution
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Outcome_Physical
CMV or invasive fungal infections
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Outcome_Physical
chronic GVHD
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Outcome_Mortality
long-term survival
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Outcome_Physical
mucotoxicity
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Participant_Condition
graft-versus-host disease ( GVHD ) after related donor allogeneic hematopoietic cell transplantation ( HCT ) .
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Participant_Condition
allogeneic hematopoietic stem cell transplantation ( HCT )
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Participant_Condition
allogeneic HCT recipients .