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
Overview
- Phase
- Phase 2
- Intervention
- Palifermin
- Conditions
- Non-Hodgkin's Lymphoma or Hodgkin's Disease
- Sponsor
- European Society for Blood and Marrow Transplantation
- Locations
- 1
- Primary Endpoint
- To test palifermin's effect on the T-cell dependent humoral immune response to recall antigen (Prevenar™)
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chemosensitive low/high grade B-NHL or T-NHL, Multiple Myeloma (MM) in partial or complete remission
- •ALL and AML, secondary AML and biphenotypic acute leukemia in complete remission (CR1 or CR2) or PR (only if ≤20% blasts in BM), Myelodysplastic syndrome (MDS)
- •CML in chronic or accelerated phase
- •Osteomyelofibrosis (OMF)
- •Hodgkin lymphoma (HD) in partial or complete remission
- •Age ≥18 years, ≤ 65 years
- •ECOG status ≤2
- •Prior treatment with 3 or less different chemotherapy regimens (not cycles); prior local radiotherapy is allowed except radiation involving the thymus
- •Adequate pulmonary function
- •Left ventricular ejection fraction (LVEF) \>30%
Exclusion Criteria
- •History of or concurrent cancer (\< 5 years ago) other than those named in inclusion criteria
- •Primary chemorefractory disease
- •CML in blast crisis
- •MM with no or minor response to previous treatment
- •Prior treatment with palifermin, or other keratinocyte growth factors
- •Documented hypersensitivity to palifermin, E. coli-derived proteins, or any component of the product
- •Documented hypersensitivity to Prevenar vaccine or its components
- •Prior allogeneic or tandem PBPC transplantation (no more than 1 previous autologous transplantation
- •Prior total body irradiation
- •Post thymectomy
Arms & Interventions
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).
Intervention: Palifermin
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).
Intervention: Placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- To assess if Palifermin improves T-cell reconstitution after haploidentical allogeneic transplantation(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(at 2 years)
- To assess drug related safety(at 2 years)