drugset / Trial / NCT01156350

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

NCT01156350 ↗

Phase 2 Unknown 10 enrolled University Hospital, Clermont-Ferrand
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-09
Primary completion
2013-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Busulfan Small molecule 4.8 mg/kg Intravenous
Background Fludarabine Small molecule 180 mg/m2 —

Indications