In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma (CTCL)

Study Overview
=================
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 dendritic/CD 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.

Official Title
-----------------
In Vitro Evaluation of Immune Responses in CTCL

Conditions
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females <18 years of age Histologically confirmed stage IV cutaneous T-cell lymphoma, with at least 5% of the peripheral blood lymphocytes showing atypical morphology consistent with Sezary cells Ambulatory and be in stable medical condition Biopsy positive mycosis fungoides/CTCL or clonal type of CTCL as determined by PCR for TCR and Southern blot for TCR Exclusion Criteria: Received any chemotherapy or radiotherapy within 4 weeks prior to enrollment Significant psychiatric illness which would prevent adequate informed consent in the opinion of the principal investigator Systemic steroid therapy other than maintenance for adrenal suppression Known coagulopathy for non SS subjects.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity of dendritic cells in-vitro | 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) | At each cell collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate antigen loading of dendritic cells | Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion) | At each cell collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Immune Responses