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

NCT05718674 | Completed

• 1 other identifier: 3594
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Vs Host Disease; Extracorporeal Photopheresis

Keywords

Extracorporeal Photopheresis

Outcome Measures

Primary Outcomes (6)

• 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

• WBC in cell product

  total WBC count x10\^9 collected and infused during ECP

  2 years

• Lymphocytes and Monocytes in cell product

  total Lymphocytes and Monocytes count x10\^9 collected and infused during ECP

  2 years

• ECP Procedure runtime

  Total procedure runtime in minutes

  2 years

• peripheral blood immunophenotype

  CD4/CD8 ratio in peripheral blood of patients undergoing ECP

  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

  2 years

Study Arms (1)

ECP patient

Patients with chronic or acute GvHD after allogeneic haematopoietic stem cell transplantation undergoing extracorporeal photopheresis

Procedure: Extracorporeal Photopheresis

Interventions

Extracorporeal Photopheresis PROCEDURE

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.

Also known as: ECP

ECP patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.

Roma, Italy

Location

Related Publications (5)

• 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.

  PMID: 29446444 BACKGROUND

• 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.

  PMID: 30284302 BACKGROUND

• 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.

  PMID: 27456672 BACKGROUND

• 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.

  PMID: 28833438 BACKGROUND

• 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.

  PMID: 31682286 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapeutic Apheresis Director

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: May 26, 2022
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)