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

Graft Versus Host Disease Clinical Trial

— IMMUNO-PEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03438643
• Other study ID #: 2017_29
• Secondary ID: 2017-A01889-44
• Status: Recruiting
• Start date: May 7, 2018
• Est. completion date: November 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Ibrahim YAKOU BAGHA, MD,PhD
• Phone: 320 444 176
• Email: ibrahim.yakoubagha[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Photopheresis
• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Diagnostic Test:
• Blood samples
Blood samples (42mL) will be taken before and during treatment.
• skin biopsy
skin biopsy will be taken before and during treatment.

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.		at 6-week follow-up
Secondary	Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD.		at 22-week follow-up
Secondary	Response rate (complete and partial response) according to NIH criteria	Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)	at 10 weeks and at 22 weeks
Secondary	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
Secondary	QLQ-C30 version 3.0	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	between 10-week and 22-week follow-ups.