Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study 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 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.


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.


NCT ID:

NCT00177190


Primary Contact:

Principal Investigator
Larisa J. Geskin, M.D.
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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