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

NCT00177190 | Completed DMC

• 1 other identifier: 0307015
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous T-cell Lymphoma; Sezary Syndrome; Mycosis Fungoides

Keywords

Cutaneous T-cell Lymphoma; Sezary Syndrome; Mycosis Fungoides; Immune Responses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate antigen loading of dendritic cells

  At each cell collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cutaneous Lymphoma Clinic patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

White cells

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Sezary Syndrome; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Larisa J. Geskin, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2006
• Last Updated: May 28, 2014

Record last verified: 2013-06

Locations

US (1)