Haploidentical Stem Cell Transplantation in Neuroblastoma
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ClinicalTrials.gov Identifier: NCT00790413 |
Recruitment Status :
Active, not recruiting
First Posted : November 13, 2008
Last Update Posted : February 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Neuroblastoma | Drug: iodine I 131 metaiodobenzylguanidine Drug: Fludarabine Drug: Thiotepa Procedure: T-cell depletion Procedure: Haploidentical stem cell transplantation Procedure: Donor Lymphocyte Infusion Drug: Rituximab Procedure: Co-transplantation of mesenchymal stem cells | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | High-dose MIBG With Subsequent Transplantation of Haploidentical Stem Cells in Children With Therapy Resistant Neuroblastoma |
Study Start Date : | August 2005 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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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
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Drug: iodine I 131 metaiodobenzylguanidine Drug: Fludarabine Drug: Thiotepa Procedure: T-cell depletion Procedure: Haploidentical stem cell transplantation Procedure: Donor Lymphocyte Infusion Drug: Rituximab Procedure: Co-transplantation of mesenchymal stem cells |
- Engraftment rate [ Time Frame: day 100 ]
- Overall survival [ Time Frame: 1 year ]
- Immunological reconstitution [ Time Frame: day 100 ]
- Incidence of acute graft versus host disease [ Time Frame: day 100 ]

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Ages Eligible for Study: | 6 Months to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Refractory neuroblastoma (any chemo/radiosensitive stable disease)
- Relapse incl. autologous HSCT 3 m earlier
- Primary induction failure
- Cardiac output SF ≥25%
- Creatinine clearance ≥40 cc/min/1.73 m2
- Performance score of ≥50% (Lansky or Karnofsky)
- Available haploidentical family donor, aged ≥18 yrs, HIV-neg
Exclusion Criteria:
- Rapidly progressive disease
- Pregnancy

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): NCT00790413
Sweden | |
Lund University Hospital, Department of Pediatric Oncology and Bone Marrow Transplantation | |
Lund, Sweden, 221 85 |
Principal Investigator: | Jacek Toporski, MD, PhD | Lund University Hospital, Department of Pediatric Oncology |
Other Publications:
Responsible Party: | Jacek Toporski, MD, PhD, Lund University Hospital |
ClinicalTrials.gov Identifier: | NCT00790413 |
Other Study ID Numbers: |
385/2005 |
First Posted: | November 13, 2008 Key Record Dates |
Last Update Posted: | February 21, 2021 |
Last Verified: | February 2021 |
Radiotherapy Immunotherapy Hematopoietic Stem Cell Transplantation |
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 Rituximab Fludarabine Thiotepa |
3-Iodobenzylguanidine Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Enzyme Inhibitors Radiopharmaceuticals |