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

September 11, 2023 updated by: Piccirillo Nicola, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli (FPG) - IRCCS.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cells
Time Frame: 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 years
WBC in cell product
Time Frame: 2 years
total WBC count x10^9 collected and infused during ECP
2 years
Lymphocytes and Monocytes in cell product
Time Frame: 2 years
total Lymphocytes and Monocytes count x10^9 collected and infused during ECP
2 years
ECP Procedure runtime
Time Frame: 2 years
Total procedure runtime in minutes
2 years
peripheral blood immunophenotype
Time Frame: 2 years
CD4/CD8 ratio in peripheral blood of patients undergoing ECP
2 years
The response
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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