Myelodysplastic Syndrome Clinical Trial
Official title:
Randomised Placebo-Controlled Double-Blind Phase II Study Applying Palifermin to Improve T-cell Immune Reconstitution After Haploidentical Allogeneic Peripheral Blood Progenitor Cell (PBPC) Transplantation
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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