Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
- Conditions
- Graft Versus Host DiseaseExtracorporeal Photopheresis
- Interventions
- Diagnostic Test: Blood samplesDiagnostic Test: skin biopsy
- Registration Number
- NCT03438643
- Lead Sponsor
- University Hospital, Lille
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients aged ≥18 years who had a first allo-CSH for hematological pathology
- Body weight ≥ 40 kg.
- Confirmed diagnosis of inaugural cGVHD requiring systemic treatment.
- Any source of hematopoietic stem cells is allowed.
- All conditioning treatments are allowed.
- Patient validated by the local investigator as eligible for treatment with ECP according to the criteria of the investigating centers
- Patient treated according to the study plan with a ECP in 2 steps
- Patient having signed informed consent.
- Prophylaxis of GVH maintained during the onset of cGVHD is accepted.
- Effective contraception for men and women of childbearing age.
- cGVHD ≥ 2nd line of treatment
- Exclusive pulmonary cGVHD
- cGVHD before J100
- cGVHD occurring after Donor Lymphocyte Injection (DLI)
- Overlaps syndrome aGVHD-cGVHD
- Late aGVHD
- Relapsed patient or progressive disease
- Non-controlled infection
- Second Allograft
- Leukopenia <0.5G / l at screening
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient Blood samples Patients treated with ECP and corticosteroid as first-line treatment for cGVHD Patient skin biopsy Patients treated with ECP and corticosteroid as first-line treatment for cGVHD
- Primary Outcome Measures
Name Time Method Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD. at 6-week follow-up
- Secondary Outcome Measures
Name Time Method Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD. at 22-week follow-up Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up. at baseline, at 6 week follow-up Response rate (complete and partial response) according to NIH criteria at 10 weeks and at 22 weeks Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)
QLQ-C30 version 3.0 between 10-week and 22-week follow-ups. 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
Trial Locations
- Locations (1)
Hôpital Claude Huriez, CHU
🇫🇷Lille, France