Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01460914
Recruitment Status : Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Frederick Lansigan, Dartmouth-Hitchcock Medical Center

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
Cutaneous T Cell Lymphoma Graft Versus Host Disease

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.

Layout table for study information
Study Type : Observational
Estimated 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 : October 2011
Estimated Primary Completion Date : September 2050
Estimated Study Completion Date : October 2050





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


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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Exclusion Criteria:

- None specified


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
Layout table for location information
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
Layout table for additonal information
Responsible Party: Frederick Lansigan, Assistant Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460914    
Other Study ID Numbers: D11271
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Keywords provided by Frederick Lansigan, Dartmouth-Hitchcock Medical Center:
ECP
CTCL
Extracorporeal photopheresis
Cutaneous T Cell Lymphoma
GVHD
Graft versus host disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Graft vs Host Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin