NCT03438643

Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Graft Versus Host Disease
• Extracorporeal Photopheresis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood samples	Blood samples (42mL) will be taken before and during treatment.
DIAGNOSTIC_TEST	skin biopsy	skin biopsy will be taken before and during treatment.

Timeline

• Start date: 2018-05-07
• Primary completion: 2019-12-02
• Completion: 2019-12-02
• First posted: 2018-02-20
• Last updated: 2025-12-23

Locations

1 site across 1 country: France