Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429416
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2007-01-29
Brief Title:
Research Study to Determine if an Experimental Agent LLME Can Decrease the Incidence and Severity of Graft-Versus-Host-Disease GVHD Following Blood Hematopoietic Stem Cell Transplantation
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Phase III Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this research study is to determine if an experimental agent LLME can decrease the incidence and severity of Graft-Versus-Host-Disease GVHD following blood hematopoietic stem cell transplantation
Detailed Description:
We believe that the risks of allogeneic transplant can be drastically reduced if the following criteria can be met 1 consistent engraftment 2 little or no GVHD with the ability to rapidly withdraw immune suppression 3 rapid recovery of CD4 counts to levels greater than 200 cellsmicro liter Our prior ongoing trial attempts to address how LLME treated T cells given as donor lymphocyte infusion DLI can address points 2 and 3 above The current study addresses how treatment of the CD34- fraction of the graft attempts to address points 1 and 2 and to a lesser extent point 3 above We believe that if these points can be consistently achieved that the mortality of allogeneic HSCT may be reduced to levels more akin to those of autologous HSCT We propose to test the hypothesis that LLME-treated T cells will be safe with regard to reducing GVHD or other infusion related toxicities and that their administration as part of the transplant will facilitate engraftment We believe that this approach will ultimately be an important step in a variety of transplant settings ranging from matched siblings to haplodisparate donors
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 |
|---|---|---|---|
| 2003-68 | OTHER | CCRRC | None |