Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017654
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-06-06
Brief Title:
Study of Allogeneic Bone Marrow and T-Cell Depleted CD34 Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia
Sponsor:
Northwestern Memorial Hospital
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
OBJECTIVES
I Determine the effect of supplementation with donor T-cell depleted CD34 peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation
I Determine the effect of supplementation with donor T-cell depleted CD34 peripheral blood stem cells on durable engraftment and incidence of graft-versus-host disease in patients with aplastic anemia undergoing allogeneic bone marrow transplantation
Detailed Description:
PROTOCOL OUTLINE Bone marrow and peripheral blood stem cells PBSC are harvested from a HLA identical or 1 antigen mismatched related donor PBSC are selected for CD34 cells and T cells are depleted
Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and anti-thymocyte globulin IV with methylprednisolone IV over 10-12 hours on days -5 to -3 T-cell depleted PBSC and bone marrow are infused on day 0 Patients receive cyclosporine IV over 12-24 hours on days -1 to 120 followed by a taper and methylprednisolone IV on days 7-64 for graft-versus-host disease prophylaxis
Patients are followed every 30 days for 1 year every 60 days for 2 years and then as needed for a minimum of 3 years
Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and anti-thymocyte globulin IV with methylprednisolone IV over 10-12 hours on days -5 to -3 T-cell depleted PBSC and bone marrow are infused on day 0 Patients receive cyclosporine IV over 12-24 hours on days -1 to 120 followed by a taper and methylprednisolone IV on days 7-64 for graft-versus-host disease prophylaxis
Patients are followed every 30 days for 1 year every 60 days for 2 years and then as needed for a minimum of 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-96H | None | None | None |
| NU-96AA1T | None | None | None |