Status:
COMPLETED
Theralux Extracorporeal Photochemotherapy (ECP) in Patients With Extensive Chronic Graft Versus Host Disease (GvHD)
Lead Sponsor:
Kiadis Pharma
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the tolerability and safety of two intensity levels of Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid refractory or intolera...
Detailed Description
Graft versus host disease (GvHD) remains a major cause of morbidity and mortality related to allogeneic stem cell transplantation. While improvements in immuno-suppressive regimens have reduced the fr...
Eligibility Criteria
Inclusion
- Clinical features compatible with extensive chronic GvHD
- Refractory or intolerant to standard therapy
Exclusion
- Pregnant or lactating women
- Underlying concurrent medical condition which would hinder the ability to safely administer the treatment
- Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Participation to another investigational trial within 30 days of study entry
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00248365
Start Date
November 1 2005
End Date
August 1 2007
Last Update
February 25 2016
Active Locations (4)
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1
B.C. Cancer Research Center
Vancouver, British Columbia, Canada, V5Z 1L3
2
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
3
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
4
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4