Trials / Withdrawn
WithdrawnNCT00570999
Palifermin After Haploidentical PBSCT
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- European Society for Blood and Marrow Transplantation · Network
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Non-Hodgkin's Lymphoma or Hodgkin's Disease
- Acute Leukaemia
- Myelodysplastic Syndrome
- Chronic Myeloid Leukemia
- Osteomyelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palifermin | 60 mg/kg/day |
| OTHER | Placebo | 1,2 mL once daily |
Timeline
- Start date
- 2008-02-01
- Completion
- 2013-01-01
- First posted
- 2007-12-11
- Last updated
- 2012-05-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00570999. Inclusion in this directory is not an endorsement.