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

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

Tracking Information

• First Submitted Date: October 19, 2011
• First Posted Date: October 27, 2011
• Last Update Posted Date: May 5, 2020
• Study Start Date: October 2011
• Estimated Primary Completion Date: September 2050 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2011)

Response rates [ Time Frame: 1 year ]

Response rates to ECP treatment

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 26, 2011)

Complications [ Time Frame: 1 year ]

Complications to ECP procedures

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment
• Official Title: Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis
• 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.
• 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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients who receive ECP treatment at DHMC

Condition

• Cutaneous T Cell Lymphoma
• Graft Versus Host Disease

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 26, 2011): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2050
• Estimated Primary Completion Date: September 2050 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01460914
• Other Study ID Numbers: D11271
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Frederick Lansigan, Dartmouth-Hitchcock Medical Center
• Study Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frederick Lansigan, MD; Dartmouth-Hitchcock Medical Center

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: May 2020