Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177190
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2005-09-12
Brief Title:
In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma CTCL
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
In Vitro Evaluation of Immune Responses in CTCL
Status:
COMPLETED
Status Verified Date:
2013-06
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 is an in vitro evaluation of cutaneous T-cell lymphoma using patients blood and tissue to evaluate immune responses related to identified tumor populations and dendriticCD 8 cells
Detailed Description:
This is an in vitro evaluation of cutaneous T-cell lymphoma using patients blood and tissue to evaluate immune responses related to identified tumor populations and dendritic CD 8 cells with the following objectives
Objective I Evaluate the feasibility of the preparation of dendritic cells DCs CD8 and Sezary cells all CD4 positive in vitro obtained from the buffy coats or a skin biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma CTCL and Sezary syndrome leukemic stage of CTCL undergoing an approved FDA therapy extracorporeal photopheresis ECP
Objective II Evaluate antigen loading of the DCs
Objective III Test the functional capacities of the DCs derived from CTCL subjects to overcome immune tolerance to the tumor cells ex-vivo by using modified Elispot assay in conjunction with Granzyme B Elispot assay as a measurement of cytotoxicity
Objective I Evaluate the feasibility of the preparation of dendritic cells DCs CD8 and Sezary cells all CD4 positive in vitro obtained from the buffy coats or a skin biopsy from an area with tumor involvement of subjects with cutaneous t-cell lymphoma CTCL and Sezary syndrome leukemic stage of CTCL undergoing an approved FDA therapy extracorporeal photopheresis ECP
Objective II Evaluate antigen loading of the DCs
Objective III Test the functional capacities of the DCs derived from CTCL subjects to overcome immune tolerance to the tumor cells ex-vivo by using modified Elispot assay in conjunction with Granzyme B Elispot assay as a measurement of cytotoxicity
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