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

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University of Pittsburgh

Status

Completed

Conditions

Cutaneous T-cell Lymphoma
Mycosis Fungoides
Sezary Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT00177190
0307015

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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