Clinical trial NCT03438643: Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
Official title: Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Graft Versus Host Disease
Extracorporeal Photopheresis
Keywords: Graft versus host disease
Extracorporeal photopheresis
Immunomodulatory
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with ECP and corticosteroid as first-line treatment for cGVHD.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
timeFrame: at 6-week follow-up
Secondary outcomes:
measure: Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD.
timeFrame: at 22-week follow-up
measure: Response rate (complete and partial response) according to NIH criteria
timeFrame: at 10 weeks and at 22 weeks
measure: Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up.
timeFrame: at baseline, at 6 week follow-up
measure: QLQ-C30 version 3.0
timeFrame: between 10-week and 22-week follow-ups.
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Ibrahim YAKOU BAGHA, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: