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

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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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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