An observational study in Graft Versus Host Disease and Extracorporeal Photopheresis, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Observational
Extracorporeal photopheresis (ECP) is a cellular therapy indicated in the treatment of chronic GVHD (cGVHD). In this study protocol, patients suffering from inaugural cGVHD will be treated with the association of ECP and corticosteroid treatment. Treatment will start by an induction stage with 2 sessions of ECP per week until the 10th week followed by a maintenance stage including one session every other week until the 22th week. The objective of this study is to highlight the immunological mechanism of extracorporeal photopheresis treatment. Indeed, ECP is based on an immunomodulatory immunological effect and despite several hypotheses highlighted by different teams; clear mechanisms still need to be defined. This French multicenter study realize an immunological follow-up before and during treatment to elucidate the impact of ECP on immune system of responder patient.
Patients treated with ECP and corticosteroid as first-line treatment for cGVHD.
Exclusion Criteria:
Patients treated with ECP and corticosteroid as first-line treatment for cGVHD
Diagnostic Test: Blood samples · Diagnostic Test: skin biopsy
Blood samples (42mL) will be taken before and during treatment.
skin biopsy will be taken before and during treatment.
Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
Time frame: at 6-week follow-up
Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD.
Time frame: at 22-week follow-up
Response rate (complete and partial response) according to NIH criteria
Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)
Time frame: at 10 weeks and at 22 weeks
Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up.
Time frame: at baseline, at 6 week follow-up
QLQ-C30 version 3.0
Evaluation of the quality of life for patients. QLQ-C30 is a composite score. QLQ-C30 Summary Score = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 10 0-Fatigue+ 100 * Pain+ 100 * Nausea\_Vomiting+ 100 * Dyspnoea+ 100 * Sleeping Disturbances+ 100 * Appetite Loss+ 100 * Constipation+ 100 * Diarrhoea)/13
Time frame: between 10-week and 22-week follow-ups.
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille