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Completed

NCT Number: NCT00177190

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Functional capacity of dendritic cells in-vitro

    Time frame: At each cell collection

    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)

Secondary outcomes

  1. Evaluate antigen loading of dendritic cells

    Time frame: At each cell collection

    Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

In Vitro Evaluation of Immune Responses in CTCL

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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