Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176852
Status:
COMPLETED
Last Update Posted:
2020-02-27
First Post:
2005-09-12
Brief Title:
Stem Cell Transplant for Hemoglobinopathy
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathy Using a Preparative Regimen to Achieve Stable Mixed Chimerism
Status:
COMPLETED
Status Verified Date:
2020-02
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:
This study tests the clinical outcomes of one of two preparative regimens determined by available donor source in patients with non-malignant hemoglobinopathies The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease
Regimen A2 has replaced Regimen A in this study Two patients were treated on Regimen A but did not have evidence of initial engraftment thus triggering the stopping rule for that arm of this study
Regimen A2 has replaced Regimen A in this study Two patients were treated on Regimen A but did not have evidence of initial engraftment thus triggering the stopping rule for that arm of this study
Detailed Description:
Prior to transplantation subjects will receive either
Cyclophosphamide Fludarabine Campath Total body irradiation TBI
Or
Busulfan Cyclophosphamide antithymocyte globulin ATG granulocyte colony-stimulating factor GSCF
These drugs and the radiation are being given to help the new stem cells take and grow On the day of transplantation subjects will receive stem cells transfused via intravenous IV catheter
After stem cell transplantation subjects will be given cyclosporine-A and mycophenolate MMFor Methylprednisoneor Methotrexate to reduce the risk of graft-versus-host disease the complication that occurs when the donors stem cells react against the patient
Cyclophosphamide Fludarabine Campath Total body irradiation TBI
Or
Busulfan Cyclophosphamide antithymocyte globulin ATG granulocyte colony-stimulating factor GSCF
These drugs and the radiation are being given to help the new stem cells take and grow On the day of transplantation subjects will receive stem cells transfused via intravenous IV catheter
After stem cell transplantation subjects will be given cyclosporine-A and mycophenolate MMFor Methylprednisoneor Methotrexate to reduce the risk of graft-versus-host disease the complication that occurs when the donors stem cells react against the patient
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 |
|---|---|---|---|
| 0206M26241 | OTHER | IRB University of Minnesota | None |