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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01460914
Other study ID # D11271
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2011
Est. completion date October 2050

Study information

Verified date August 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date October 2050
Est. primary completion date September 2050
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who receive Extracorporeal Photopheresis treatment - Treated at Dartmouth-Hitchcock Medical Center - Must be 18 years or older Exclusion Criteria: - None specified

Study Design


Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rates Response rates to ECP treatment 1 year
Secondary Complications Complications to ECP procedures 1 year
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