Ignite Creation Date:
2024-05-06 @ 2:53 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02158767
Status:
AVAILABLE
Last Update Posted:
2023-05-25
First Post:
2014-06-05
Brief Title:
Access Protocol Infusion of CD34 Enriched T Cell Depleted Hematopoietic Stem Cell Grafts
Sponsor:
Leland Metheny
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Access Protocol Infusion of CD34 Enriched T Cell Depleted Hematopoietic Stem Cell Grafts
Status:
AVAILABLE
Status Verified Date:
2024-07
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 clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels One way of improving the blood counts in the recipient is to give a booster dose of cells from the donor but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells To decrease this risk it is possible to decrease the amount of T cells responsible for this type of immune reaction These cells are removed by a special handling of the graft which allows to remove the cells directly or indirectly by selecting other cells to stay in the graft
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels One way of improving the blood counts in the recipient is to give a booster dose of cells from the donor but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells To decrease this risk it is possible to decrease the amount of T cells responsible for this type of immune reaction These cells are removed by a special handling of the graft which allows to remove the cells directly or indirectly by selecting other cells to stay in the graft
Detailed Description:
PRIMARY OBJECTIVES
I To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived cluster of differentiation CD34 enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System
OUTLINE
Patients undergo CD34 enriched or T-cell depleted peripheral blood stem cell infusion PBSCT over 1-3 hours
After completion of study treatment patients are followed up for 100 days
I To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived cluster of differentiation CD34 enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System
OUTLINE
Patients undergo CD34 enriched or T-cell depleted peripheral blood stem cell infusion PBSCT over 1-3 hours
After completion of study treatment patients are followed up for 100 days
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