Clinical trial NCT05718674: Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
Official title: Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Graft Vs Host Disease
Extracorporeal Photopheresis
Keywords: Extracorporeal Photopheresis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of GvHD post allogeneic HSC transplantation being treated with photopheresis;
* signing of informed consent (IC) and consent to personal data processing

Exclusion Criteria:

-

Primary outcomes:
measure: The cells
timeFrame: 2 years
measure: WBC in cell product
timeFrame: 2 years
measure: Lymphocytes and Monocytes in cell product
timeFrame: 2 years
measure: ECP Procedure runtime
timeFrame: 2 years
measure: peripheral blood immunophenotype
timeFrame: 2 years
measure: The response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.
Study officials:
References:
citation: 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.
citation: Bueno 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.
citation: Brosig 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.
citation: Piccirillo 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.
citation: Piccirillo 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.