Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176826
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2005-09-12
Brief Title:
T-Cell Depletion and Stem Cell Transplant for Immune Deficiencies and Histiocytic Disorders
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
In-vivo T-cell Depletion and Hematopoietic Stem Cell Transplantation for Life-Threatening Immune Deficiencies and Histiocytic Disorders
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Replaced by another protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis is to determine if a preparative regimen of busulfan cyclophosphamide and antithymocyte globulin ATG plus allogeneic stem cell transplantation will be effective in the treatment of immune deficiencies and histiocytic disorders
Detailed Description:
Subjects will begin chemotherapy as a preparative regimen which is intended to completely eliminate their defective immune system and bone marrow The preparative regimen consists of the chemotherapy drugs busulfan cyclophosphamide and antithymocyte globulin ATG
Transplantation subjects will then have a source of blood stem cells bone marrow from their donor administered into their catheter Medication will be given to help prevent Graft-Versus Host Disease GVHD The ATG will help to deplete the donor stem cells of the type of cells that can cause GVHD and will also help to promote engraftment of the new stem cells
Recovery Phase The second phase of treatment consists of a period after transplantation during which we wait for the return of bone marrow function This usually takes two to four weeks Subjects will be given a blood cell growth factor G-CSF to help speed recovery of the white blood cells and potentially decrease the risk of infection and decrease the time until the bone marrow recovers
Transplantation subjects will then have a source of blood stem cells bone marrow from their donor administered into their catheter Medication will be given to help prevent Graft-Versus Host Disease GVHD The ATG will help to deplete the donor stem cells of the type of cells that can cause GVHD and will also help to promote engraftment of the new stem cells
Recovery Phase The second phase of treatment consists of a period after transplantation during which we wait for the return of bone marrow function This usually takes two to four weeks Subjects will be given a blood cell growth factor G-CSF to help speed recovery of the white blood cells and potentially decrease the risk of infection and decrease the time until the bone marrow recovers
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 |
|---|---|---|---|
| 0010M66781 | OTHER | Institutional Review Board University of Minnesota | None |