Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product

Graft Vs Host Disease Clinical Trial

— 3594  

Official title:

Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05718674
• Other study ID #: 3594
• Status: Enrolling by invitation
• Start date: May 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Extracorporeal Photopheresis
• Graft Vs Host Disease

Intervention

Procedure:
• Extracorporeal Photopheresis
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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 extr — View 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. — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	WBC in cell product	total WBC count x10^9 collected and infused during ECP	2 years
Primary	Lymphocytes and Monocytes in cell product	total Lymphocytes and Monocytes count x10^9 collected and infused during ECP	2 years
Primary	ECP Procedure runtime	Total procedure runtime in minutes	2 years
Primary	peripheral blood immunophenotype	CD4/CD8 ratio in peripheral blood of patients undergoing ECP	2 years
Primary	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	2 years