Graft Versus Host DiseaseIMMUNO-PECNCT03438643
Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
An observational study of Graft Versus Host Disease and Extracorporeal Photopheresis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease, Extracorporeal Photopheresis
- What is being tested?
- Blood samples and skin biopsy
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2018to 2 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with ECP and corticosteroid as first-line treatment for cGVHD.
Who may be able to join
- 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
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- 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.
Who cannot join
- cGVHD ≥ 2nd line of treatment
- Exclusive pulmonary cGVHD
- cGVHD before J100
- cGVHD occurring after Donor Lymphocyte Injection (DLI)
- Overlaps syndrome aGVHD-cGVHD
- Late aGVHD
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- Relapsed patient or progressive disease
- Non-controlled infection
- Second Allograft
- Leukopenia <0.5G / l at screening
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Blood samples, skin biopsy
- Keywords
- Graft versus host disease, Extracorporeal photopheresis, Immunomodulatory
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Blood samples (42mL) will be taken before and during treatment.
skin biopsyDiagnostic test
skin biopsy will be taken before and during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients treated with ECP and corticosteroid as first-line treatment for cGVHD Receives: Diagnostic Test: Blood samples; Diagnostic Test: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
Measured: at 6-week follow-up
Secondary outcomes (4)
Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD.
Measured: at 22-week follow-up
Response rate (complete and partial response) according to NIH criteria
Efficacy of ECP in inaugural cGVHD in combination with immunosuppressive therapy (prednisone + ciclosporin)
Measured: at 10 weeks and at 22 weeks
Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up.
Measured: at baseline, at 6 week follow-up
QLQ-C30 version 3.0
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
Measured: between 10-week and 22-week follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start7 May 2018
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Why it stopped: lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim YAKOU BAGHA, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438643
- Sponsor's protocol ID
- 2017_29
- Other IDs
- 2017-A01889-44
- Acronym
- IMMUNO-PEC
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT03438643
- Acronym / sponsor ID
- IMMUNO-PEC / 2017_29
- Keywords
- Graft versus host disease, Extracorporeal photopheresis, Immunomodulatory
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusions
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Diagnostic Test: Blood samples, Diagnostic Test: skin biopsyPatients treated with ECP and corticosteroid as first-line treatment for cGVHD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with ECP and corticosteroid as first-line treatment for cGVHD.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- cGVHD ≥ 2nd line of treatment
- Exclusive pulmonary cGVHD
- cGVHD before J100
- cGVHD occurring after Donor Lymphocyte Injection (DLI)
- Overlaps syndrome aGVHD-cGVHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples (42mL) will be taken before and during treatment. | Diagnostic test | Patient |
| skin biopsyskin biopsy will be taken before and during treatment. | Diagnostic test | Patient |
Primary outcome
Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
Time frame: at 6-week follow-up
4 secondary outcomes
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
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.
Results and safety
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim YAKOU BAGHA, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease and Extracorporeal Photopheresis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD. (time frame: at 6-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.