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

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

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

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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


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438643


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

Locations
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France
Hôpital Claude Huriez, CHU Recruiting
Lille, France
Principal Investigator: Ibrahim Yakoub-Agha, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Ibrahim YAKOU BAGHA, MD,PhD University Hospital, Lille

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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    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: May 2018

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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:
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Graft vs Host Disease
Immune System Diseases