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

Study Overview
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Brief Summary
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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.

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

Conditions
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Graft Versus Host Disease, Extracorporeal Photopheresis

Intervention / Treatment
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* Diagnostic Test: Blood samples
* Diagnostic Test: skin biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient<br>Patients treated with ECP and corticosteroid as first-line treatment for cGVHD | Diagnostic Test: Blood samples<br>* Blood samples (42mL) will be taken before and during treatment.<br>Diagnostic Test: skin biopsy<br>* skin biopsy will be taken before and during treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD. |  | 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) | 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. |  | 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 | between 10-week and 22-week follow-ups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft versus host disease, Extracorporeal photopheresis, Immunomodulatory