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

NCT ID: NCT03438643

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-07

Study Completion Date

2019-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Graft Versus Host Disease Extracorporeal Photopheresis

Keywords

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Graft versus host disease Extracorporeal photopheresis Immunomodulatory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient

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

Blood samples

Intervention Type DIAGNOSTIC_TEST

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

skin biopsy

Intervention Type DIAGNOSTIC_TEST

skin biopsy will be taken before and during treatment.

Interventions

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Blood samples

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

Intervention Type DIAGNOSTIC_TEST

skin biopsy

skin biopsy will be taken before and during treatment.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ibrahim YAKOU BAGHA, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01889-44

Identifier Type: OTHER

Identifier Source: secondary_id

2017_29

Identifier Type: -

Identifier Source: org_study_id