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

U

University Hospital, Lille

Status

Enrolling

Conditions

Extracorporeal Photopheresis
Graft Versus Host Disease

Treatments

Diagnostic Test: skin biopsy
Diagnostic Test: Blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT03438643
2017_29
2017-A01889-44 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

40 participants in 1 patient group

Patient
Description:
Patients treated with ECP and corticosteroid as first-line treatment for cGVHD
Treatment:
Diagnostic Test: Blood samples
Diagnostic Test: skin biopsy

Trial contacts and locations

1

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Central trial contact

Ibrahim YAKOU BAGHA, MD,PhD

Data sourced from clinicaltrials.gov

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