- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460914
Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment
August 4, 2023 updated by: Frederick Lansigan, Dartmouth-Hitchcock Medical Center
Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis
Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV light.
ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also effective for graft-versus-host disease (GVHD).
The investigators would like to study the outcomes (response rates) of patients receiving ECP treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.
Study Overview
Status
Active, not recruiting
Detailed Description
The investigators intend to report outcomes from the inception of this procedure at Dartmouth-Hitchcock Medical Center (DHMC) in May 2008 through 9/30/11.
Additionally, the investigators would like to maintain a prospective database of these patients so that new patient data can be collected for updating of outcomes.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who receive ECP treatment at DHMC
Description
Inclusion Criteria:
- Patients who receive Extracorporeal Photopheresis treatment
- Treated at Dartmouth-Hitchcock Medical Center
- Must be 18 years or older
Exclusion Criteria:
- None specified
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rates
Time Frame: 1 year
|
Response rates to ECP treatment
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 1 year
|
Complications to ECP procedures
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frederick Lansigan, MD, Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Estimated)
September 1, 2050
Study Completion (Estimated)
October 1, 2050
Study Registration Dates
First Submitted
October 19, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (Estimated)
October 27, 2011
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D11271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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