Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242515
Status:
UNKNOWN
Last Update Posted:
2014-01-08
First Post:
2005-10-19
Brief Title:
T-cell Depleted Donor Lymphocyte Infusion DLIfor Acute Myeloid Leukemia AML or High Risk Myelodysplastic Syndrome MDS
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Preemptive CD8 T-cell Depleted Donor Lymphocyte Infusion DLI Following Nonmyeloablative Stem Cell Transplantation NMT for Acute Myeloid Leukemia AML or High Risk Myelodysplastic Syndrome MDS
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
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:
Primary Objectives
This a pilot project to determine the feasibility of the preemptive CD8 depleted T-cell donor lymphocyte infusion DLI in
Reducing the incidence of graft versus host disease GVHD based on standard classification of acute and chronic GVHD
Improving hte disease remission rate in comparison with our previous study results
Secondary Objectives
To investigate the impact of CD8 depleted T-cell DLI in hematopoietic chimerism and immunologic recovery of transplant patients
This a pilot project to determine the feasibility of the preemptive CD8 depleted T-cell donor lymphocyte infusion DLI in
Reducing the incidence of graft versus host disease GVHD based on standard classification of acute and chronic GVHD
Improving hte disease remission rate in comparison with our previous study results
Secondary Objectives
To investigate the impact of CD8 depleted T-cell DLI in hematopoietic chimerism and immunologic recovery of transplant patients
Detailed Description:
The scientific investigation in this study protocol
1 Define the role of preemptive and specific DLI in preserving the GVL effect in the setting of NMT The ability of selecting components of T cells for transplant and DLI will allow us to test the hypothesis of distinctive roles in subsets of T cells It was found that CD8-depleted DLI was administered to prevent relapse after TCD T-cell depleted BMT bone marrow as the stem cell source or CD34-selected PBSC
Whether preemptive CD8-depleted DLI can perform this function after nonmyeloablative transplantation NMT needs to be established as proposed in our study If there turns out to be a role for DLI in these circumstances a CD8-depleted lymphocyte product that can limit GVHD would be a very attractive option We would also define the relationship of the level of donor chimerism and disease control
2 Investigate the impact of CD8-depleted DLI in NMT at specific doses and time points for the reduction of GVHD The GVHD pattern may vary between different ethnic populations as suggested by our earlier NMT study Our current proposed study will further shed light on the optimal GVHD prophylaxis regimen in the Singapore patient population
1 Define the role of preemptive and specific DLI in preserving the GVL effect in the setting of NMT The ability of selecting components of T cells for transplant and DLI will allow us to test the hypothesis of distinctive roles in subsets of T cells It was found that CD8-depleted DLI was administered to prevent relapse after TCD T-cell depleted BMT bone marrow as the stem cell source or CD34-selected PBSC
Whether preemptive CD8-depleted DLI can perform this function after nonmyeloablative transplantation NMT needs to be established as proposed in our study If there turns out to be a role for DLI in these circumstances a CD8-depleted lymphocyte product that can limit GVHD would be a very attractive option We would also define the relationship of the level of donor chimerism and disease control
2 Investigate the impact of CD8-depleted DLI in NMT at specific doses and time points for the reduction of GVHD The GVHD pattern may vary between different ethnic populations as suggested by our earlier NMT study Our current proposed study will further shed light on the optimal GVHD prophylaxis regimen in the Singapore patient population
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