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 currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01460914
First received: October 19, 2011
Last updated: October 13, 2014
Last verified: October 2014
  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 ] [ Designated as safety issue: No ]
    Response rates to ECP treatment


Secondary Outcome Measures:
  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460914

Contacts
Contact: Frederick Lansigan, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Frederick Lansigan, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Principal Investigator: Frederick Lansigan, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460914     History of Changes
Other Study ID Numbers: D11271
Study First Received: October 19, 2011
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014