drugset / Trial / NCT00570999

Palifermin After Haploidentical PBSCT

NCT00570999

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or Kepivance®). The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also been suggested to have an ability to help improve the reconstitution, or development, of the immune system after the transplantation. The hypothesis is that the patients T-cell dependent humoral immune response to recall antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo control group

Timeline

Start
2008-02
Primary completion
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Palifermin Protein / enzyme biologic 60 mg/kg