Graft Vs Host Disease3594NCT05718674
Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
An observational study of Graft Vs Host Disease and Extracorporeal Photopheresis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is an observational study on extracorporeal photopheresis,an established therapy for the treatment of Graft versus Host Disease (GvHD) post allogeneic haemopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease, Extracorporeal Photopheresis
- What is being tested?
- Extracorporeal Photopheresis
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2022to 30 Jul 2025
- 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: The study population is represented by patients affected by chronic or acute GVHD after allogeneic haematopoietic stem cell transplantation treated at the 'Haematology' and 'Laboratory and DH of Haematology' units undergoing photopheretic treatment in Apheresis Unit of the Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.
Who may be able to join
- diagnosis of GvHD post allogeneic HSC transplantation being treated with photopheresis;
- signing of informed consent (IC) and consent to personal data processing
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.
Roma
About this study
This is an observational study on extracorporeal photopheresis,an established therapy for the treatment of Graft versus Host Disease (GvHD) post allogeneic haemopoietic stem cell transplantation. There are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells.
The investigators will enrol patients undergoing allogeneic transplants and extracorporeal photopheresis in order to understand whether the different ways in which photopheresis is performed affect cell products and clinical response.
Read the detailed description
The FPG Stem Cell Transplantation Programme has indicated extracorporeal photopheresis as the therapy of choice for the second-line treatment of steroid-resistant GvHD. If efficacy is supported by clear evidence in the literature, less clear are the mechanism of action, the qualitative and quantitative characteristics of the cells responsible for the clinical response, and the impact of procedural and instrumental variables on clinical efficacy. Indeed, there are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells.
The investigators designed a prospective study that aims to collect data on patients, photopheresis procedures and related cellular products. The analysis of the data will allow the investigators to define the qualitative and quantitative characteristics of the cell products, associating them with the different techniques and instruments, and looking for possible associations with clinical response.
The data collected will be able to contribute to the characterisation of the techniques, procedures and the definition of a minimum cell dose to be treated in order to obtain the response. The aim is to define the volume to be processed or the number of procedures to be carried out by analogy with what is now established practice for the collection procedures of other autologous or allogeneic therapeutic cells (stem cells, lymphocytes, granulocytes), laying the foundations for optimising the treatments and resources employed.
- Being tested
- Extracorporeal Photopheresis
- Keywords
- Extracorporeal Photopheresis
- 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.
Extracorporeal PhotopheresisProcedure or surgery
Also called ECP
ECP is performed by collecting leucocytes from the patient through leukopheresis and incubating them with 8-MOP and UVA in extracorporeal circulation. The treatment steps are the collection of leucocytes, photoactivation and subsequent reinfusion of the treated cells.
| Study group | Role | What they receive |
|---|---|---|
| ECP patient | Patients with chronic or acute GvHD after allogeneic haematopoietic stem cell transplantation undergoing extracorporeal photopheresis Receives: Procedure: Extracorporeal Photopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cells
Primary endpoints:
- To evaluate qualitative and quantitative characteristics of white blood cells in patients undergoing photopheresis. Laboratory tests usually performed in patients undergoing allogeneic transplant and Photopheresis (complete white blood cell count, peripheral blood immunophenotype) will be performed in peripheral blood samples taken before treatment and in samples of cell products collected during treatment. The data obtained will be analysed in relation to the different instruments and techniques used.
Measured: 2 years
WBC in cell product
total WBC count x10^9 collected and infused during ECP
Measured: 2 years
Lymphocytes and Monocytes in cell product
total Lymphocytes and Monocytes count x10^9 collected and infused during ECP
Measured: 2 years
ECP Procedure runtime
Total procedure runtime in minutes
Measured: 2 years
peripheral blood immunophenotype
CD4/CD8 ratio in peripheral blood of patients undergoing ECP
Measured: 2 years
The response
Secondary endpoints:
- To evaluate the association between the qualitative and quantitative characteristics of white blood cells and the clinical response of patients undergoing photopheresis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start26 May 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Graft Vs 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piccirillo Nicola, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718674
- Sponsor's protocol ID
- 3594
- Acronym
- 3594
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Worel N, Lehner E, Fuhrer H, Kalhs P, Rabitsch W, Mitterbauer M, Hopfinger G, Greinix HT. Extracorporeal photopheresis as second-line therapy for patients with acute graft-versus-host disease: does the number of cells treated matter? Transfusion. 2018 Apr;58(4):1045-1053. doi: 10.1111/trf.14506. Epub 2018 Feb 15.
PubMed 29446444Bueno JL, Alonso R, Gonzalez-Santillana C, Naya D, Romera I, Alarcon A, Aguilar M, Bautista G, Duarte R, Ussetti P, Cabrera JR. A paired trial comparing mononuclear cell collection in two machines for further inactivation through an inline or offline extracorporeal photopheresis procedure. Transfusion. 2019 Jan;59(1):340-346. doi: 10.1111/trf.14975. Epub 2018 Oct 4.
PubMed 30284302Brosig A, Hahnel V, Orso E, Wolff D, Holler E, Ahrens N. Technical comparison of four different extracorporeal photopheresis systems. Transfusion. 2016 Oct;56(10):2510-2519. doi: 10.1111/trf.13728. Epub 2016 Jul 26.
PubMed 27456672Piccirillo N, Putzulu R, Massini G, Fiore AG, Chiusolo P, Sica S, Zini G. Mononuclear cell collection for extracorporeal photopheresis: Concentrate characteristics for off-line UV-A irradiation procedure. J Clin Apher. 2018 Jun;33(3):217-221. doi: 10.1002/jca.21574. Epub 2017 Aug 22.
PubMed 28833438Piccirillo N, Putzulu R, Massini G, Di Giovanni A, Chiusolo P, Sica S, Zini G. Inline extracorporeal photopheresis: evaluation of cell collection efficiency. Transfusion. 2019 Dec;59(12):3714-3720. doi: 10.1111/trf.15570. Epub 2019 Nov 4.
PubMed 31682286
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
- ClinicalTrials.gov ID
- NCT05718674
- Acronym / sponsor ID
- 3594 / 3594
- Keywords
- Extracorporeal Photopheresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Feb 2023 (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.
This is an observational study on extracorporeal photopheresis,an established therapy for the treatment of Graft versus Host Disease (GvHD) post allogeneic haemopoietic stem cell transplantation. There are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells.
The investigators will enrol patients undergoing allogeneic transplants and extracorporeal photopheresis in order to understand whether the different ways in which photopheresis is performed affect cell products and clinical response.
Detailed description
The FPG Stem Cell Transplantation Programme has indicated extracorporeal photopheresis as the therapy of choice for the second-line treatment of steroid-resistant GvHD. If efficacy is supported by clear evidence in the literature, less clear are the mechanism of action, the qualitative and quantitative characteristics of the cells responsible for the clinical response, and the impact of procedural and instrumental variables on clinical efficacy. Indeed, there are different techniques and devices to perform cell collection procedure, photoactivation and infusion of mononuclear cells.
The investigators designed a prospective study that aims to collect data on patients, photopheresis procedures and related cellular products. The analysis of the data will allow the investigators to define the qualitative and quantitative characteristics of the cell products, associating them with the different techniques and instruments, and looking for possible associations with clinical response.
The data collected will be able to contribute to the characterisation of the techniques, procedures and the definition of a minimum cell dose to be treated in order to obtain the response. The aim is to define the volume to be processed or the number of procedures to be carried out by analogy with what is now established practice for the collection procedures of other autologous or allogeneic therapeutic cells (stem cells, lymphocytes, granulocytes), laying the foundations for optimising the treatments and resources employed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECP patient | – | Procedure: Extracorporeal PhotopheresisPatients with chronic or acute GvHD after allogeneic haematopoietic stem cell transplantation undergoing extracorporeal photopheresis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is represented by patients affected by chronic or acute GVHD after allogeneic haematopoietic stem cell transplantation treated at the 'Haematology' and 'Laboratory and DH of Haematology' units undergoing photopheretic treatment in Apheresis Unit of the Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.
Key inclusion criteria (2 listed)
- diagnosis of GvHD post allogeneic HSC transplantation being treated with photopheresis;
- signing of informed consent (IC) and consent to personal data processing
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Extracorporeal PhotopheresisAlso: ECPECP is performed by collecting leucocytes from the patient through leukopheresis and incubating them with 8-MOP and UVA in extracorporeal circulation. The treatment steps are the collection of leucocytes, photoactivation and subsequent reinfusion of the treated cells. | Procedure or surgery | ECP patient |
Primary outcome
The cells
Time frame: 2 years
Primary endpoints: - To evaluate qualitative and quantitative characteristics of white blood cells in patients undergoing photopheresis. Laboratory tests usually performed in patients undergoing allogeneic transplant and Photopheresis (complete white blood cell count, peripheral blood immunophenotype) will be performed in peripheral blood samples taken before treatment and in samples of cell products collected during treatment. The data obtained will be analysed in relation to the different instruments and techniques used.
WBC in cell product
Time frame: 2 years
total WBC count x10^9 collected and infused during ECP
Lymphocytes and Monocytes in cell product
Time frame: 2 years
total Lymphocytes and Monocytes count x10^9 collected and infused during ECP
ECP Procedure runtime
Time frame: 2 years
Total procedure runtime in minutes
peripheral blood immunophenotype
Time frame: 2 years
CD4/CD8 ratio in peripheral blood of patients undergoing ECP
The response
Time frame: 2 years
Secondary endpoints: - To evaluate the association between the qualitative and quantitative characteristics of white blood cells and the clinical response of patients undergoing photopheresis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Results publication: PubMed 29446444Worel N, Lehner E, Fuhrer H, Kalhs P, Rabitsch W, Mitterbauer M, Hopfinger G, Greinix HT. Extracorporeal photopheresis as second-line therapy for patients with acute graft-versus-host disease: does the number of cells treated matter? Transfusion. 2018 Apr;58(4):1045-1053. doi: 10.1111/trf.14506. Epub 2018 Feb 15.
- Results publication: PubMed 30284302Bueno JL, Alonso R, Gonzalez-Santillana C, Naya D, Romera I, Alarcon A, Aguilar M, Bautista G, Duarte R, Ussetti P, Cabrera JR. A paired trial comparing mononuclear cell collection in two machines for further inactivation through an inline or offline extracorporeal photopheresis procedure. Transfusion. 2019 Jan;59(1):340-346. doi: 10.1111/trf.14975. Epub 2018 Oct 4.
- Results publication: PubMed 27456672Brosig A, Hahnel V, Orso E, Wolff D, Holler E, Ahrens N. Technical comparison of four different extracorporeal photopheresis systems. Transfusion. 2016 Oct;56(10):2510-2519. doi: 10.1111/trf.13728. Epub 2016 Jul 26.
- Results publication: PubMed 28833438Piccirillo N, Putzulu R, Massini G, Fiore AG, Chiusolo P, Sica S, Zini G. Mononuclear cell collection for extracorporeal photopheresis: Concentrate characteristics for off-line UV-A irradiation procedure. J Clin Apher. 2018 Jun;33(3):217-221. doi: 10.1002/jca.21574. Epub 2017 Aug 22.
- Results publication: PubMed 31682286Piccirillo N, Putzulu R, Massini G, Di Giovanni A, Chiusolo P, Sica S, Zini G. Inline extracorporeal photopheresis: evaluation of cell collection efficiency. Transfusion. 2019 Dec;59(12):3714-3720. doi: 10.1111/trf.15570. Epub 2019 Nov 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vs Host Disease and Extracorporeal Photopheresis, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The cells (time frame: 2 years). The study lists 6 primary outcomes in all. 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 NCT05718674, which also lists 5 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 14 Aug 2025.