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

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.

Study Overview

• Status: Terminated
• Conditions: Graft Versus Host Disease; Extracorporeal Photopheresis
• Intervention / Treatment: Diagnostic test: Blood samples; Diagnostic test: skin biopsy

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Claude Huriez, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)	at 10 weeks and at 22 weeks
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	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): December 2, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Graft versus host disease; Immunomodulatory; Extracorporeal photopheresis
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2017_29; 2017-A01889-44 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No