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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
60 mg/kg/day
1,2 mL once daily
Dr Ruth Seggewiss
Würzburg, Germany
To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™)
Time frame: at study day +270 (20 days after the third Prevenar injection)
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Time frame: at study days: +240
To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation
Time frame: Study days +210, +240, +270
To assess disease free survival (DFS) and overall survival (OS), incidence and duration of GvHD, incidence and severity of OM, and incidence and severity of infections
Time frame: at 2 years
To assess drug related safety
Time frame: at 2 years
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