Haploidentical Stem Cell Transplantation in Neuroblastoma

Sponsor
Lund University Hospital
Study ID
NCT00790413
Phase
EARLY_PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • iodine I 131 metaiodobenzylguanidine — DRUG
  • Fludarabine — DRUG
  • Thiotepa — DRUG
  • T-cell depletion — PROCEDURE
  • Haploidentical stem cell transplantation — PROCEDURE
  • Donor Lymphocyte Infusion — PROCEDURE
  • Rituximab — DRUG
  • Co-transplantation of mesenchymal stem cells — PROCEDURE

Study Details

Children with primary resistant or relapsed neuroblastoma who do not achieve remission with conventional chemotherapy have extremely dismal prognosis. A novel treatment strategy combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (MIBG) and immunotherapeutic effect of haploidentical stem cell transplantation (haploSCT) followed by low-dose donor lymphocyte infusions will be piloted. The use of the isotope is aimed to decrease pre-transplant tumour burden. Reduced intensity conditioning containing Fludarabine, Thiotepa and Melfalan will enable sustained engraftment as well as will serve as additional anti-tumor treatment. A prompt natural killer (NK)-cell mediated tumour control may be achieved by haploidentical stem cell transplantation. The investigators hypothesize that tumour cells potentially evading NK-cell mediated immunity may be targeted by infused donor T-cells and eliminated by either MHC-dependent manner or through a bystander effect. The possible graft versus tumor effect will be evaluated in children with therapy resistant neuroblastoma.

Key Dates

Start date
Aug 31, 2005
Status verified
Feb 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose MIBG with haploidentical stem cell transplantation
    High-dose MIBG followed by Fludarabine, Thiotepa and Melfalan as conditioning Before haploidentical transplantation of T-cell depleted graft

Primary Outcome Measure

Engraftment rate [ Time Frame: day 100 ]

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