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Trial record 1 of 1 for:    NCT01460914
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Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460914
First Posted: October 27, 2011
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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.

Condition
Cutaneous T Cell Lymphoma Graft Versus Host Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Response rates [ Time Frame: 1 year ]
    Response rates to ECP treatment


Secondary Outcome Measures:
  • Complications [ Time Frame: 1 year ]
    Complications to ECP procedures


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: October 2050
Estimated Primary Completion Date: September 2050 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who receive ECP treatment at DHMC
Criteria

Inclusion Criteria:

  • Patients who receive Extracorporeal Photopheresis treatment
  • Treated at Dartmouth-Hitchcock Medical Center
  • Must be 18 years or older
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460914


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460914     History of Changes
Other Study ID Numbers: D11271
First Submitted: October 19, 2011
First Posted: October 27, 2011
Last Update Posted: May 5, 2016
Last Verified: May 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
ECP
CTCL
Extracorporeal photopheresis
Cutaneous T Cell Lymphoma
GVHD
Graft versus host disease

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Graft vs Host Disease
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin