Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma

Neuroblastoma Clinical Trial

— Rice NK  

Official title:

Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01156350
• Other study ID #: CHU-0075
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 28, 2010
• Last updated: January 18, 2011
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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 CD3/CD19 graft depletion may allow HHCT with lower toxicity and faster engraftment. CD3/CD19 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• High Risk Neuroblastoma

• HLA haplo-identical family donor

Exclusion Criteria:

• patient with fast progressive neuroblastoma

• Lansky < 60%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• Busulfan - Fludarabine - TBI
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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		at one year	Yes
Secondary	Study of the overall survival Study of graft versus tumor effect at day + 100		at day + 100	Yes