Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
1 Year
18 Years
Both
Neuroblastoma
Trial Information
Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
This RICE NK protocol is a multicenter study of Haplo- HSCT using RIC with fludarabine (180
mg/m2), Busulfan IV (3,2 to 4,8 mg/kg/d), TBI 2 grays and CD3/CD19 graft depletion. A
minimum of 8 106 CD34+ cells/kg were infused on day 0. No post grafting immunosuppression
was applied if the graft contained < 2.5 x 104 CD3+ cells/kg. 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.
Inclusion Criteria:
- High Risk Neuroblastoma
- HLA haplo-identical family donor
Exclusion Criteria:
- patient with fast progressive neuroblastoma
- Lansky < 60%
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of the feasibility of the CD3 / CD19 selected haplo identical hematopoietic stem cell transplant after conditioning with reduced intensity in children with neuroblastoma in failure of reference treatments
Outcome Time Frame:
at one year
Safety Issue:
Yes
Principal Investigator
Catherine PAILLARD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Ministry of Health
Study ID:
CHU-0075
NCT ID:
NCT01156350
Start Date:
September 2011
Completion Date:
September 2014
Related Keywords:
- Neuroblastoma
- Neuroblastoma - Haplo HSCT - Reduced Intensity Conditioning - immunotherapy NK
- Neuroblastoma
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