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3594: Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05718674
Collaborator
(none)
30
Enrollment
1
Location
25.2
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

We 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Extracorporeal Photopheresis

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.

We designed a prospective study that aims to collect data on patients, photopheresis procedures and related cellular products. The analysis of the data will allow us 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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell Product
Actual Study Start Date :
May 26, 2022
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
ECP patient

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

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.
Other Names:
  • ECP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 photopheresis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS. Roma Italy

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piccirillo Nicola, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05718674
    Other Study ID Numbers:
    • 3594
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Piccirillo Nicola, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Extracorporeal Photopheresis
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Feb 8, 2023