Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01462396
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2011-10-25
Brief Title:
Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Phase I Study of Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using Major Histocompatibility Complex MHC Mismatched Related Donors and Sub-Myeloablative Regimen
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STALLO
Brief Summary:
Allogeneic stem cell transplantation has been explored for patients with high risk neuroblastoma Results have been mixed with only small series and case reports Recent reports however especially with haploidentical transplantation have been more encouraging Eradication of neuroblastoma may be mediated by both components of the innate immune system natural killer cells and through the adaptive immune system via T-cell cytotoxicity and the development of a humoral response to tumor specific antigens and minor histocompatibility antigens To overcome restrictions created by unavailability of Human leukocyte antigen HLA matched donors stem cell grafts from haploidentical related donors have been explored Historically the use of full haplotype mismatched family member donors has been limited by the development of severe graft-versus-host disease and the high rate of graft failure Graft failure can now be overcome by increasing immunosuppression and increasing the number of transplanted stem cells The most effective means of graft versus host disease GVHD prophylaxis is T cell depletion of the donor marrow A 3-4 log depletion will reduce the risk of developing significant GVHD to less than 10 Methods to mobilize stem cells from the bone marrow into the peripheral blood and collect these stem cells by apheresis now increase the availability of stem cells by a magnitude Selection devices have been developed that will prepare extremely pure populations of these CD34 cells with upwards of 5 logs depletion of contaminating T cells The CliniMACS CD34 Reagent System is a medical device designed to select CD34 hematopoietic cells from heterogeneous hematologic cell populations The investigators intend to provide mismatched related hematopoietic stem cell transplantation to up to 10 patients with relapsed refractory neuroblastoma Harnessing the potential for innate and adaptive immune responses through allogeneic Hematopoietic stem cell transplantation HSCT may provide cure for some patients with this tumor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None