Status:
TERMINATED
Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
Lead Sponsor:
University Hospital, Lille
Conditions:
Graft Versus Host Disease
Extracorporeal Photopheresis
Eligibility:
All Genders
18+ years
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 as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 2 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03438643
Start Date
May 7 2018
End Date
December 2 2019
Last Update
December 23 2025
Active Locations (1)
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1
Hôpital Claude Huriez, CHU
Lille, France