Cutaneous T-cell LymphomaNCT00177190
In Vitro Evaluation of Immune Responses in Cutaneous T-Cell Lymphoma (CTCL)
An observational study of Cutaneous T-cell Lymphoma and Sezary Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cutaneous Lymphoma Clinic patients
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: In Vitro Evaluation of Immune Responses in 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.
Read the detailed 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.
- Keywords
- Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Immune Responses
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Sezary Syndrome, Mycosis Fungoides
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At each cell collection
Secondary outcomes (1)
Evaluate antigen loading of dendritic cells
Functional DCs can be isolated and effectively loaded with the malignant cells by several methods (coculture and fusion)
Measured: At each cell collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larisa Geskin, University of Pittsburgh
- Investigators
- Larisa J. Geskin, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177190
- Sponsor's protocol ID
- 0307015
- Status last verified
- Jun 2013
- First submitted
- 12 Sep 2005
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Evaluation of Immune Responses in CTCL
- ClinicalTrials.gov ID
- NCT00177190
- Acronym / sponsor ID
- 0307015
- Keywords
- Cutaneous T-cell Lymphoma, Sezary Syndrome, Mycosis Fungoides, Immune Responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cutaneous Lymphoma Clinic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Evaluate antigen loading of dendritic cells
Time frame: At each cell collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa J. Geskin, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous T-cell Lymphoma and Sezary Syndrome, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity of dendritic cells in-vitro (time frame: At each cell collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.