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 : November 19, 2020
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Condition or disease | Intervention/treatment |
---|---|
Graft Versus Host Disease Extracorporeal Photopheresis | Diagnostic Test: Blood samples Diagnostic Test: skin biopsy |
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
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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. |
- Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD. [ Time Frame: at 6-week follow-up ]
- 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 ]
- 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)
- 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 ]
- 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 |
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

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
Contact: Ibrahim YAKOU BAGHA, MD,PhD | 320 444 176 ext +33 | ibrahim.yakoubagha@chru-lille.fr |
France | |
Hôpital Claude Huriez, CHU | Recruiting |
Lille, France | |
Principal Investigator: Ibrahim Yakoub-Agha, MD,PhD |
Principal Investigator: | Ibrahim YAKOU BAGHA, MD,PhD | University Hospital, Lille |
Responsible Party: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT03438643 |
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: | November 19, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Graft versus host disease Extracorporeal photopheresis Immunomodulatory |
Graft vs Host Disease Immune System Diseases |