Extracorporeal Photopheresis, Graft Versus Host Disease
Conditions
Keywords
Graft versus host disease, Extracorporeal photopheresis, Immunomodulatory
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.
Interventions
DIAGNOSTIC_TESTBlood samples
Blood samples (42mL) will be taken before and during treatment.
DIAGNOSTIC_TESTskin biopsy
skin biopsy will be taken before and during treatment.
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | at 10 weeks and at 22 weeks | Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin) |
| 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 | 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 |
Countries
France
Outcome results
None listed