IMMUNO-PEC: Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT03438643

Collaborator

(none)

Enrollment

Location

33.8

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease Extracorporeal Photopheresis	Diagnostic Test: Blood samples Diagnostic Test: skin biopsy

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 7, 2018

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Patient

Patients treated with ECP and corticosteroid as first-line treatment for cGVHD

Diagnostic Test: Blood samples

Blood samples (42mL) will be taken before and during treatment.

Diagnostic Test: skin biopsy

skin biopsy will be taken before and during treatment.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Claude Huriez, CHU	Lille		France

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Ibrahim YAKOU BAGHA, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT03438643

Other Study ID Numbers:

2017_29
2017-A01889-44

First Posted:

Feb 20, 2018

Last Update Posted:

Nov 19, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Graft versus host disease

Extracorporeal photopheresis

Immunomodulatory

Additional relevant MeSH terms:

Graft vs Host Disease

Study Results

No Results Posted as of Nov 19, 2020