Informations générales (source: ClinicalTrials.gov)
Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease (IMMUNO-PEC)
Observational
University Hospital, Lille (Voir sur ClinicalTrials)
mai 2018
novembre 2023
04 janvier 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Claude Huriez, CHU - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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