NCT01460914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2015

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

3.3 years

First QC Date

October 19, 2011

Last Update Submit

September 18, 2024

Conditions

Cutaneous T Cell LymphomaGraft Versus Host Disease

Keywords

ECPCTCLExtracorporeal photopheresisCutaneous T Cell LymphomaGVHDGraft versus host disease

Outcome Measures

Primary Outcomes (1)

  • Response rates

    Response rates to ECP treatment

    1 year

Secondary Outcomes (1)

  • Complications

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive ECP treatment at DHMC

You may qualify if:

  • Patients who receive Extracorporeal Photopheresis treatment
  • Treated at Dartmouth-Hitchcock Medical Center
  • Must be 18 years or older

You may not qualify if:

  • \- None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Weber LL, Dunbar NM, Meehan KR, Szczepiorkowski ZM, Lansigan F. Successful implementation of a rural extracorporeal photopheresis program for the treatment of cutaneous T-cell lymphoma and chronic graft-versus-host disease in a rural hospital. J Clin Apher. 2015 Dec;30(6):359-63. doi: 10.1002/jca.21382. Epub 2015 Feb 17.

    PMID: 25691106RESULT

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousGraft vs Host Disease

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Frederick Lansigan, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 27, 2011

Study Start

October 1, 2011

Primary Completion

January 6, 2015

Study Completion

January 6, 2015

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

US(1)