Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01460914
Collaborator
(none)
100
1
468
0.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    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
    Study Start Date :
    Oct 1, 2011
    Anticipated Primary Completion Date :
    Sep 1, 2050
    Anticipated Study Completion Date :
    Oct 1, 2050

    Outcome Measures

    Primary Outcome Measures

    1. Response rates [1 year]

      Response rates to ECP treatment

    Secondary Outcome Measures

    1. Complications [1 year]

      Complications to ECP procedures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who receive Extracorporeal Photopheresis treatment

    • Treated at Dartmouth-Hitchcock Medical Center

    • Must be 18 years or older

    Exclusion Criteria:
    • None specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frederick Lansigan, Assistant Professor of Medicine, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT01460914
    Other Study ID Numbers:
    • D11271
    First Posted:
    Oct 27, 2011
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Frederick Lansigan, Assistant Professor of Medicine, Dartmouth-Hitchcock Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 2, 2021