Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325741
Status:
TERMINATED
Last Update Posted:
2023-08-15
First Post:
2006-05-12
Brief Title:
Allogeneic Blood Stem Cell Transplantation for Patients With Life-Threatening Systemic Lupus Erythematosus
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Allogeneic Hematopoietic Cell Transplantation for Patients With Life-Threatening Systemic Lupus Erythematosus Using a Non-Myeloablative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with recruiting participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLE
Brief Summary:
The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood and Marrow Transplantation BMT are enrolling patients with severe systemic lupus erythematosus SLE that is resistant to standard treatment prednisone and cyclophosphamide Cytoxan into a new study to determine if they can be successfully treated with a blood stem cell transplantation obtained from an appropriate donor Donors will be human leukocyte antigen HLA-matched healthy brothers or sisters For patients without sibling HLA-matches a search for donors will be initiated through the US and International Donor Registries Eligible patients must be at least 18 years old and have SLE with progressive kidney lung heart or central nervous system disease that has not responded to standard therapy
Patients will be treated for two weeks to prepare them for the infusion of blood stem cells that are obtained from their HLA-matched donor Patients will initially be treated with immunosuppressive drugs which will be gradually withdrawn at approximately 6 months after transplantation The goal of this study is to replace the abnormal immune cells of the SLE affected patient that causes the disease with normal immune cells that are generated from the transplant blood stem cells from the healthy donor
Patients will be treated for two weeks to prepare them for the infusion of blood stem cells that are obtained from their HLA-matched donor Patients will initially be treated with immunosuppressive drugs which will be gradually withdrawn at approximately 6 months after transplantation The goal of this study is to replace the abnormal immune cells of the SLE affected patient that causes the disease with normal immune cells that are generated from the transplant blood stem cells from the healthy donor
Detailed Description:
The purpose of this study is to evaluate the effectiveness of allogeneic blood stem cell transplantation in individuals with life-threatening SLE A non-bone marrow ablative regimen consisting of total lymphoid irradiation TLI and anti-thymocyte globulin ATG will be used to condition the recipients for transplantation Appropriately HLA-matched donors will undergo mobilization of their peripheral blood mononuclear cells using G-CSF and collection by apheresis
The preparative regimen will consist of targeted low dose radiation of lymphoid tissue administered over a 2-week period of time During the first week of irradiation the patients will also receive the ATG treatment Patients will be admitted to the in-patient service for the first 5 days of the transplant preparative regimen while receiving the ATG infusion Patients will be discharged for the second half of the preparative regimen and followed in the out-patient clinic thereafter Patients will start immunosuppressive treatment with cyclosporine and mycophenolate mofetil prior to the infusion of mobilized peripheral blood stem cells The mycophenolate mofetil will be stopped at approximately 1 month post-transplantation and the cyclosporine will be tapered beginning at 2 months post-transplantation and discontinued by 6 months in the presence of stable blood chimerism and the absence of graft-versus-host disease In the pre-transplant and post-transplant setting patients will be evaluated by an integrated team of Rheumatology and BMT physicians During the first 21-28 days post-transplantation these evaluations will be performed on a daily or every other day basis Patients will be clinically assessed and evaluated for engraftment of donor cells and disease response Patients will then be followed as needed with maximum time between evaluations of 1 to 2 weeks in the first 100 days and then monthly for 6 months and every 6 months to 12 months thereafter
The preparative regimen will consist of targeted low dose radiation of lymphoid tissue administered over a 2-week period of time During the first week of irradiation the patients will also receive the ATG treatment Patients will be admitted to the in-patient service for the first 5 days of the transplant preparative regimen while receiving the ATG infusion Patients will be discharged for the second half of the preparative regimen and followed in the out-patient clinic thereafter Patients will start immunosuppressive treatment with cyclosporine and mycophenolate mofetil prior to the infusion of mobilized peripheral blood stem cells The mycophenolate mofetil will be stopped at approximately 1 month post-transplantation and the cyclosporine will be tapered beginning at 2 months post-transplantation and discontinued by 6 months in the presence of stable blood chimerism and the absence of graft-versus-host disease In the pre-transplant and post-transplant setting patients will be evaluated by an integrated team of Rheumatology and BMT physicians During the first 21-28 days post-transplantation these evaluations will be performed on a daily or every other day basis Patients will be clinically assessed and evaluated for engraftment of donor cells and disease response Patients will then be followed as needed with maximum time between evaluations of 1 to 2 weeks in the first 100 days and then monthly for 6 months and every 6 months to 12 months thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL075462-02 | NIH | None | httpsreporternihgovquickSearchP01HL075462-02 |