In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma (CTCL)
This study has been completed.
Information provided by:
University of Pittsburgh
First received: September 12, 2005
Last updated: January 12, 2010
Last verified: January 2010
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.
Cutaneous T-Cell Lymphoma
||Time Perspective: Prospective
||In Vitro Evaluation of Immune Responses in CTCL
Biospecimen Retention: Samples Without DNA
| Study Start Date:
| Study Completion Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Cutaneous Lymphoma Clinic patients
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177190
|University of Pittsburgh Medical Center
|Pittsburgh, Pennsylvania, United States, 15213 |
University of Pittsburgh
||Larisa J. Geskin, M.D.
||University of Pittsburgh
No publications provided
||Larisa Geskin, MD, University of Pittsburgh Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||January 12, 2010
||United States: Institutional Review Board
Keywords provided by University of Pittsburgh:
Cutaneous T-cell Lymphoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases