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

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ClinicalTrials.gov Identifier: NCT01156350
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : July 2, 2010
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2014


Arms and Interventions

Intervention Details:
    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

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 [ Time Frame: at one year ]

Secondary Outcome Measures :
  1. Study of the overall survival Study of graft versus tumor effect at day + 100 [ Time Frame: at day + 100 ]

Eligibility Criteria

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High Risk Neuroblastoma
  • HLA haplo-identical family donor

Exclusion Criteria:

  • patient with fast progressive neuroblastoma
  • Lansky < 60%
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156350


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Catherine PAILLARD University Hospital, Clermont-Ferrand
More Information

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01156350     History of Changes
Other Study ID Numbers: CHU-0075
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Neuroblastoma - Haplo HSCT - Reduced Intensity Conditioning - immunotherapy NK

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Fludarabine
Fludarabine phosphate
Busulfan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists