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

NCT03438643 | Terminated

• 2 other identifiers: 2017_292017-A01889-44
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease; Extracorporeal Photopheresis

Keywords

Graft versus host disease; Extracorporeal photopheresis; Immunomodulatory

Outcome Measures

Primary Outcomes (1)

• Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.

  at 6-week follow-up

Secondary Outcomes (4)

• 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

• 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.

Study Arms (1)

Patient

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

Diagnostic Test: Blood samples; Diagnostic Test: skin biopsy

Interventions

Blood samples DIAGNOSTIC_TEST

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

Patient

skin biopsy DIAGNOSTIC_TEST

skin biopsy will be taken before and during treatment.

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Claude Huriez, CHU

Lille, France

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ibrahim YAKOU BAGHA, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 20, 2018
• Study Start: May 7, 2018
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)