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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Denileukin Diftitox on Immune System in CTCL Patients

NCT00254332

Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides

COMPLETED

Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma

NCT00430053

Lymphoma

COMPLETED

Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma

NCT00863395

Cutaneous T-Cell Lymphoma

TERMINATED PHASE1/PHASE2

Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides

NCT01645293

CD30 Positive Cutaneous T Cell Lymphoma CD30 Positive Transformed Mycosis Fungoides

UNKNOWN PHASE1

Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research

NCT00177268

Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides +2 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cutaneous T-cell Lymphoma Sezary Syndrome Mycosis Fungoides

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No