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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01156350
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: Busulfan - Fludarabine - TBI	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Haplo-identical Hematopoietic Stem Cell Transplantation Following Reduced-intensity Conditioning in Children With Neuroblastoma
• Study Start Date: Sep 1, 2011
• Anticipated Primary Completion Date: Sep 1, 2013
• Anticipated Study Completion Date: Sep 1, 2014

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Study of the overall survival Study of graft versus tumor effect at day + 100 [at day + 100]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• High Risk Neuroblastoma

• HLA haplo-identical family donor

Exclusion Criteria:

• patient with fast progressive neuroblastoma

• Lansky < 60%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63003

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Catherine PAILLARD, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01156350
• Other Study ID Numbers: CHU-0075
• First Posted: Jul 2, 2010
• Last Update Posted: Jan 19, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Neuroblastoma - Haplo HSCT - Reduced Intensity Conditioning - immunotherapy NK
• Additional relevant MeSH terms: Neuroblastoma; Fludarabine; Busulfan

Study Results

No Results Posted as of Jan 19, 2011