Ignite Creation Date:
2024-05-05 @ 10:38 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01156350
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2010-06-28
Brief Title:
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Rice NK
Brief Summary:
To date no curative option exists for patients with relapsed or refractory stage IV neuroblastoma after previous autologous stem cell transplantation Our preliminary results of RIC allo-HSCT protocol RICE indicate the feasability and low toxicity of allograft in heavily pre-treated children Furthermore RIC SCT and immunomagnetic CD3CD19 graft depletion may allow HHCT with lower toxicity and faster engraftment CD3CD19 depleted grafts not only contain CD34 stem cells but also graft-facilitating cells CD34- progenitors dendritic and natural killer cells which may allow stable engraftment and participate to GvT effect
After haploidentical stem cell transplantation anti tumour activity exerted by donor derived NK cells could be stimulated by NK cells injections Those effects may help to reduce the relapse rate and to impove the outcome of those patients The investigators prospectively evaluated engraftment and immune reconstitution
After haploidentical stem cell transplantation anti tumour activity exerted by donor derived NK cells could be stimulated by NK cells injections Those effects may help to reduce the relapse rate and to impove the outcome of those patients The investigators prospectively evaluated engraftment and immune reconstitution
Detailed Description:
This RICE NK protocol is a multicenter study of Haplo- HSCT using RIC with fludarabine 180 mgm2 Busulfan IV 32 to 48 mgkgd TBI 2 grays and CD3CD19 graft depletion A minimum of 8 106 CD34 cellskg were infused on day 0 No post grafting immunosuppression was applied if the graft contained 25 x 104 CD3 cellskg At Day 30 and 60 post-graft we perform an donor CD56 cells injection The investigators develop this strategy in an European collaboration working on haploidentical stem cell transplantation for childhood refractory and metastatic solid tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None