An interventional study of Experimental ECP protocol in Chronic Graft Versus Host Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
At present, cGvHD is the main cause of transplant-related morbidity in patients receiving allogeneic hematopoietic stem cell transplant (allo-HSCT). Extracorporeal photopheresis (ECP) has been recognized as a second-line treatment option for steroid-resistant forms or to reduce the immunosuppressant burden. The more commonly adopted protocol consists of performing ECP procedures on two consecutive days every two weeks initially, and then once a month. The investigators hypothesized that a new ECP protocol consisting of one single apheresis procedure on day 1, processing 5000 ml of total blood volume (TBV), followed by product photo-irradiation and split into two equivalent aliquots to be administered on day 1 and 2, respectively, is safe and might improve self-reported QoL of cGVHD patients.
Patients will be randomized to control arm A (six months of standard ECP, two ECP procedures in two consecutive days) or experimental arm B (six months of experimental ECP therapy, that is, one single apheresis procedure but two product infusions) in a ratio of 1:1.
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
This study's planned enrollment of 54 is close to the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients enrolled in the standard therapy arm receive ECP treatment according to local standard procedures. In agreement with national guidelines, in the case of initial treatment (incident cGVHD), it consists of one ECP cycle (i.e. two consecutive ECP procedures) every other week for the first 12 weeks and then one ECP cycle every month. For prevalent cGVHD (\> 3 months), treatment consists of one ECP cycle (two consecutive ECP procedures) every month.
Patients enrolled in the experimental arm receive ECP treatment with the same schedule as patients in arm A (one course every two weeks in case of incident cGVHD or every month in case of prevalent cGVD). However, the ECP will be carried out using a modified standard procedure. In particular: An additional collection bag is connected to the Amicus ECP kit through sterile sealing. A total of 5000 mL of blood volume is processed through the Amicus cell separator. The 8-MOP solution is added to the apheresis product bag using the Luer-Lock connection equipped with antibacterial filters, and the product is exposed to photo-irradiation. Half the product is then transferred to the second collection bag and, after sealing, is stored in a dedicated area at 4+2°C until administration. The first aliquot is immediately transfused. The second aliquot is administered on the subsequent day within 24 hours of collection.
Other: Experimental ECP protocol
Patients enrolled in the experimental arm receive ECP treatment with the same schedule as patients in arm A (one course every two weeks in case of incident cGVHD or every month in case of prevalent cGVD). However, the ECP will be carried out using a modified standard procedure. In particular: An additional collection bag is connected to the Amicus ECP kit through sterile sealing. A total of 5000 mL of blood volume is processed through the Amicus cell separator. The 8-MOP solution is added to the apheresis product bag using the Luer-Lock connection equipped with antibacterial filters, and the product is exposed to photo-irradiation. Half the product is then transferred to the second collection bag and, after sealing, is stored in a dedicated area at 4+2°C until administration. The first aliquot is immediately transfused. The second aliquot is administered on the subsequent day within 24 hours of collection.
Mean treatment-related differences in the SF-36 scores (physical domains) collected monthly in patients in the control and experimental arms
The primary objective is to evaluate whether the proposed ECP protocol influences patient-reported QoL assessed through the Short Form-36 (SF-36) score (physical domains)
Time frame: Baseline and up to 6 months
cGVHD response rate (as evaluated according to the NIH criteria23) after six months of treatment in control and experimental arms
To evaluate the response rate in patients undergoing standard or experimental ECP procedures according to the NIH response criteria
Time frame: Baseline and up to 6 months
Mean treatment-related differences in the SF-36 scores (all domains) collected monthly in patients in the control and experimental arms
To evaluate patient-reported QoL improvement assessed through the SF-36 tool (all domains) in the standard and experimental ECP procedures
Time frame: Baseline and up to 6 months
Comparison of the total number of apoptotic cells infused in patients in the control and experimental arms
To assess the number of apoptotic cells infused per course in the standard and experimental ECP procedures
Time frame: Baseline and up to 6 months
Comparison of direct and indirect costs of ECP treatment in patients in the control and experimental arms
To compare the direct and indirect costs of the standard and experimental ECP procedures
Time frame: Through study completion, an average of 2 years
Rate of microbial contamination of day-2 products in the experimental arm
To evaluate the microbial contamination rate of day-2 products in the experimental ECP procedures
Time frame: Through study completion, an average of 2 years
Rate of adverse events at infusion in the standard and experimental arms
To evaluate adverse events at infusion in the standard and experimental ECP procedures
Time frame: Through study completion, an average of 2 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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