Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179790
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2005-09-09
Brief Title:
Reduced Intensity Transplant Using Extracorporeal Photopheresis
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Reduced Intensity Stem Cell Transplant in Children and Young Adults Utilizing Photopheresis Fludarabine and Busulfan
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
Stem cell transplantation may be used to cure childhood cancers and other diseases Traditionally stem cell transplants use high doses of chemotherapy and radiation This regimen may cause significant problems after transplant such as infertility infection and graft versus host disease GVHD
Reduced intensity transplant RIT uses medications which weaken the immune system allowing donor cells to take over The goal of a RIT is to reduce the risk for complications after transplant Usually medication is used to weaken the immune system but there are other options such as extracorporeal photopheresis ECP that may be less toxic
ECP is currently used for the treatment of GVHD and certain lymphomas ECP uses a machine that filters white blood cells from the blood treats them with ultraviolet UV light and then gives all the cells back to the patient The patients immune system becomes weaker allowing the donor cells to replace those of the patient Studies involving the use of ECP for conditioning have shown fewer side effects than the use of medications
The primary purpose of this clinical research trial is to evaluate the safety and feasibility of ECP as part of a preparative regimen for RIT in children and young adults
Reduced intensity transplant RIT uses medications which weaken the immune system allowing donor cells to take over The goal of a RIT is to reduce the risk for complications after transplant Usually medication is used to weaken the immune system but there are other options such as extracorporeal photopheresis ECP that may be less toxic
ECP is currently used for the treatment of GVHD and certain lymphomas ECP uses a machine that filters white blood cells from the blood treats them with ultraviolet UV light and then gives all the cells back to the patient The patients immune system becomes weaker allowing the donor cells to replace those of the patient Studies involving the use of ECP for conditioning have shown fewer side effects than the use of medications
The primary purpose of this clinical research trial is to evaluate the safety and feasibility of ECP as part of a preparative regimen for RIT in children and young adults
Detailed Description:
This study tests the feasibility of a reduced intensity preparative regimen for stem cell transplant including extracorporeal photopheresis ECP busulfan and fludarabine in patients with leukemia lymphoma and certain non-malignant diseases The current reduced intensity protocol includes busulfan fludarabine and anti-thymocyte immunoglobulin ECP is currently used in diseases such as chronic GVHD and cutaneous T cell lymphoma The mechanism of ECP has not been defined It is hypothesized that exposure of white blood cells to ultraviolet light with 8-methoxypsoralen initiates an apoptotic cellular cascade Apoptotic cells are recognized and removed by the reticuloendothelial system initiating the secretion of anti-inflammatory cytokines and the reduction of proinflammatory cytokines Antigen presenting cells then regulate immune responses through the induction of tolerance
Here we incorporate the use of ECP fludarabine and busulfan in the preparative regimen followed by ECP as prophylaxis for acute graft versus host disease We hypothesize that photopheresis is safe and feasible and patients will have similar rates of engraftment with less GVHD as those treated with current reduced intensity protocols The use of ECP prior to transplant provides immunosuppression promoting host engraftment Furthermore the introduction of ECP following transplant may be able to induce tolerance thereby reducing rates of GVHD
Here we incorporate the use of ECP fludarabine and busulfan in the preparative regimen followed by ECP as prophylaxis for acute graft versus host disease We hypothesize that photopheresis is safe and feasible and patients will have similar rates of engraftment with less GVHD as those treated with current reduced intensity protocols The use of ECP prior to transplant provides immunosuppression promoting host engraftment Furthermore the introduction of ECP following transplant may be able to induce tolerance thereby reducing rates of GVHD
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