Palifermin After Haploidentical PBSCT (KGF Haplo Allo)
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
Non-Hodgkin's Lymphoma or Hodgkin's Disease
Chronic Myeloid Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- 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) ] [ Designated as safety issue: No ]
- To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation [ Time Frame: at study days: +240 ] [ Designated as safety issue: No ]
- To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation [ Time Frame: Study days +210, +240, +270 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To assess drug related safety [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||January 2013|
Experimental: Arm A
Palifermin once daily at a dose of 60 mg/kg/day for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).
Placebo Comparator: Arm B
Placebo at a dose of 1.2 mL (saline 0,9%) once daily for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).
1,2 mL once daily
Other Name: 0.9% saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570999
|Dr Ruth Seggewiss|
|Würzburg, Germany, 97080|
|Study Chair:||Ruth Seggewiss, MD||University Hospital of Würzburg|