Status:
COMPLETED
Pilot Study: Patients With Chronic Active Graft Versus Host Disease That Have Failed or Not Tolerated Standard Therapy.
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Blood Stem Cell Transplant Failure
Graft Versus Host Disease
Eligibility:
All Genders
7+ years
Brief Summary
By doing this study, researchers hope to understand the many changes that occur in the blood of people who have chronic GvHD. This may also help the researcher understand how ECP works and help guide ...
Detailed Description
The occurrence of acute or chronic graft-versus-host disease (GVHD) and its prevention/treatment induce further immunologic compromise. Graft-versus-host disease (GvHD) accounts for significant morbid...
Eligibility Criteria
Inclusion
- Allogeneic HSCT recipients who have chronic extensive GvHD and who have failed or have not been able to tolerate conventional therapy
- Platelets ≥ 20,000 without transfusion support
- Weight ≥ 15 kg.
- Stated willingness to use contraception in women of childbearing potential
Exclusion
- Patients who may not be able to tolerate ECP
- Patients who have received Rituximab monoclonal antibody therapy in the past 3 months
- Patients with a known hypersensitivity to psoralens
- Pregnant or breastfeeding
- Patients who are unable to sign informed consent or who do not have a representative to give permission to participate
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01174277
Start Date
August 1 2010
End Date
February 1 2016
Last Update
January 10 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108