Chronic Graft Versus Host DiseaseEXPRESSNCT07918547
A New ECP Protocol for the Treatment of cGVHD
A study testing Experimental ECP protocol in people with Chronic Graft Versus Host Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Experimental ECP protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient age ≥18 years
- Diagnosis of incident (<3 months from diagnosis) or prevalent (>3 months from diagnosis) cGVHD
- Ability to understand and sign the informed consent form
Who cannot join
- Patient age <18 years
- Relapse of haematological disease
- Inability to comply with the study
- Patients enrolled in other interventional trials
- Refusal to sign written informed consent to study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
C. Giovanna Valentini, MD, PhD contact
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italia, 00168
C. Giovanna Valentini, +39 06 3015 4700, caterinagiovanna.valentini@policlinicogemelli.it
About this study
Official title: Extracorporeal Photopheresis for Graft Versus Host Disease: a Randomized Study Comparing One Split Product Versus Two Products' Administration. The EXPRESS Study.
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.
Read the detailed description
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.
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Experimental ECP protocol
- Keywords
- GVHD, Extracorporeal photopheresis, Quality of life, Allogeneic HSCT
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ECP protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | 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. |
| Arm B | Experimental | 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. Receives: Other: Experimental ECP protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and up to 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Giovanna Valentini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918547
- Sponsor's protocol ID
- 13659
- Acronym
- EXPRESS
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Colpo A, Marchetti M, Bianco I, Cruciani F, Ipsevich F, Montanari M, Stanghellini MTL; Italian Society of Hemapheresis and Cell Manipulation (SIdEM) and the Italian Transplant Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO). Treatment of acute and chronic graft-versus-host disease with extracorporeal photopheresis: Update of best practice recommendations from Italian Society of Hemapheresis and Cell Manipulation (SIdEM) and the Italian Transplant Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO). Transfus Apher Sci. 2024 Oct;63(5):103990. doi: 10.1016/j.transci.2024.103990. Epub 2024 Aug 13.
PubMed 39208662Lozano M, Charry P, de Pablo-Miro M, Salas MQ, Martinez C, Suarez-Lledo M, Fernandez-Aviles F, Rovira M, Cid J. Role of extracorporeal photopheresis in the management of acute and chronic graft versus disease: current status. Bone Marrow Transplant. 2024 Sep;59(9):1209-1214. doi: 10.1038/s41409-024-02360-w. Epub 2024 Jul 3.
PubMed 38961259
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Photopheresis for Graft Versus Host Disease: a Randomized Study Comparing One Split Product Versus Two Products' Administration. The EXPRESS Study.
- ClinicalTrials.gov ID
- NCT07918547
- Acronym / sponsor ID
- EXPRESS / 13659
- Conditions
- Chronic Graft Versus Host Disease
- Keywords
- GVHD, Extracorporeal photopheresis, Quality of life, Allogeneic HSCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –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. |
| Arm B | Experimental | Other: Experimental ECP protocolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age ≥18 years
- Diagnosis of incident (<3 months from diagnosis) or prevalent (>3 months from diagnosis) cGVHD
- Ability to understand and sign the informed consent form
Key exclusion criteria (5 listed)
- Patient age <18 years
- Relapse of haematological disease
- Inability to comply with the study
- Patients enrolled in other interventional trials
- Refusal to sign written informed consent to study participation
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 |
|---|---|---|
| Experimental ECP protocolPatients 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 | Arm B |
Primary outcome
Mean treatment-related differences in the SF-36 scores (physical domains) collected monthly in patients in the control and experimental arms
Time frame: Baseline and up to 6 months
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)
6 secondary outcomes
cGVHD response rate (as evaluated according to the NIH criteria23) after six months of treatment in control and experimental arms
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
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
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
Time frame: Through study completion, an average of 2 years
Rate of microbial contamination of day-2 products in the experimental arm
Time frame: Through study completion, an average of 2 years
Rate of adverse events at infusion in the standard and experimental arms
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 39208662Colpo A, Marchetti M, Bianco I, Cruciani F, Ipsevich F, Montanari M, Stanghellini MTL; Italian Society of Hemapheresis and Cell Manipulation (SIdEM) and the Italian Transplant Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO). Treatment of acute and chronic graft-versus-host disease with extracorporeal photopheresis: Update of best practice recommendations from Italian Society of Hemapheresis and Cell Manipulation (SIdEM) and the Italian Transplant Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO). Transfus Apher Sci. 2024 Oct;63(5):103990. doi: 10.1016/j.transci.2024.103990. Epub 2024 Aug 13.
- Background: PubMed 38961259Lozano M, Charry P, de Pablo-Miro M, Salas MQ, Martinez C, Suarez-Lledo M, Fernandez-Aviles F, Rovira M, Cid J. Role of extracorporeal photopheresis in the management of acute and chronic graft versus disease: current status. Bone Marrow Transplant. 2024 Sep;59(9):1209-1214. doi: 10.1038/s41409-024-02360-w. Epub 2024 Jul 3.
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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.
C. Giovanna Valentini, MD, PhD contact
Caterina Giovanna Valentini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental ECP protocol in people with Chronic Graft Versus Host Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact C. Giovanna Valentini, MD, PhD (0039 06 3015 4700, caterinagiovanna.valentini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean treatment-related differences in the SF-36 scores (physical domains) collected monthly in patients in the control and experimental arms (time frame: Baseline and up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07918547, which also lists 2 linked publications.
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 5 Nov 2026.