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

• ClinicalTrials.gov Identifier: NCT03438643
• Recruitment Status: Recruiting
• First Posted: February 20, 2018
• Last Update Posted: September 13, 2018
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Study Description

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.

Condition or disease	Intervention/treatment
Graft Versus Host Disease; Extracorporeal Photopheresis	Diagnostic Test: Blood samples; Diagnostic Test: skin biopsy

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
• Actual Study Start Date: May 7, 2018
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: March 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD. [ Time Frame: at 6-week follow-up ]

Secondary Outcome Measures :

1. Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD. [ Time Frame: at 22-week follow-up ]
2. Response rate (complete and partial response) according to NIH criteria [ Time Frame: at 10 weeks and at 22 weeks ]
   Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)
3. Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up. [ Time Frame: at baseline, at 6 week follow-up ]
4. QLQ-C30 version 3.0 [ Time Frame: between 10-week and 22-week follow-ups. ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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 aGVHD-cGVHD
• Late aGVHD
• Relapsed patient or progressive disease
• Non-controlled infection
• Second Allograft
• Leukopenia <0.5G / l at screening

Contacts and Locations

Contacts

Contact: Ibrahim YAKOU BAGHA, MD,PhD; 320 444 176 ext +33; ibrahim.yakoubagha@chru-lille.fr

Locations

France

Hôpital Claude Huriez, CHU; Recruiting

Lille, France

Principal Investigator: Ibrahim Yakoub-Agha, MD,PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

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

More Information

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03438643 History of Changes
• Other Study ID Numbers: 2017_29; 2017-A01889-44 ( Other Identifier: ID-RCB number, ANSM )
• First Posted: February 20, 2018
• Last Update Posted: September 13, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:

Graft versus host disease; Extracorporeal photopheresis; Immunomodulatory

Additional relevant MeSH terms:

Graft vs Host Disease; Immune System Diseases