Pilot Study: Patients With Chronic Active Graft Versus Host Disease That Have Failed or Not Tolerated Standard Therapy.
|ClinicalTrials.gov Identifier: NCT01174277|
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment|
|Blood Stem Cell Transplant Failure Graft Versus Host Disease||Other: Collection of blood sample|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Immunological Changes in Chronic Graft Versus Host Disease Treated With Extracorporeal Photopheresis|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Collection of blood sample
Other: Collection of blood sample
Participation involves collection of blood sample at baseline, 2, 4, 6 and 12 months regardless of whether or not patients continue on treatment.
- Determine effects of ECP using Cellex on T and B cell subsets and CD4+ cell differentiation [ Time Frame: 2 years ]Flow cytometry will be used to characterize T and B cell subsets in the blood of ECP patients. We will also isolate CD4+ T cells from ECP patients, stimulate the cells in culture, and measure proliferation and cytokine production. These assays will be performed prior to ECP therapy and at two, four and six months following ECP therapy.
- To correlate the effects of ECP on immunologic parameters with clinical outcomes. [ Time Frame: 2 years ]We will measure serum levels of eight biomarkers known to correlate with GvHD and evaluate the patients for clinical signs of GvHD. The biomarkers and clinical signs will be correlated with the immunologic parameters described in the primary outcome measure.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174277
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Sunil Abhyankar, MD||University of Kansas Medical Center|