Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
- Conditions
- Graft Vs Host DiseaseExtracorporeal Photopheresis
- Interventions
- Procedure: Extracorporeal Photopheresis
- Registration Number
- NCT05718674
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- diagnosis of GvHD post allogeneic HSC transplantation being treated with photopheresis;
- signing of informed consent (IC) and consent to personal data processing
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ECP patient Extracorporeal Photopheresis Patients with chronic or acute GvHD after allogeneic haematopoietic stem cell transplantation undergoing extracorporeal photopheresis
- Primary Outcome Measures
Name Time Method WBC in cell product 2 years total WBC count x10\^9 collected and infused during ECP
ECP Procedure runtime 2 years Total procedure runtime in minutes
peripheral blood immunophenotype 2 years CD4/CD8 ratio in peripheral blood of patients undergoing ECP
The cells 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.The response 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 photopheresisLymphocytes and Monocytes in cell product 2 years total Lymphocytes and Monocytes count x10\^9 collected and infused during ECP
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.
🇮🇹Roma, Italy