Extracorporeal Photopheresis (ECP) After Lung Transplantation

NCT ID: NCT05721079

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-12-31

Brief Summary

The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.

Detailed Description

The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.

Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.

Conditions

Lung Transplant Infection; Lung Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECP with standard triple IS

Group Type: EXPERIMENTAL

ECP (Extracorporeal Photopheresis System)

Intervention Type: DEVICE

Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.

standard triple IS

Group Type: ACTIVE_COMPARATOR

ECP (Extracorporeal Photopheresis System)

Intervention Type: DEVICE

Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.

Interventions

ECP (Extracorporeal Photopheresis System)

Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.

Intervention Type: DEVICE

Other Intervention Names

8-Methoxypsoralen

Eligibility Criteria

Inclusion Criteria

• Patients undergoing first lung transplantation
• Patient underlying disease COPD
• Male or female be 18 years or older
• Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
• Patients must have a body weight more than 40 kg
• Patients must have a platelet count more than 20.000/cmm
• Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent

Exclusion Criteria

• Previous organ transplantation
• Women who are pregnant and/or lactating
• Patients with hypersensitivity or allergy to both heparin and citrate products
• Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Peter Jaksch, Priv.Doz. Dr.

Priv.-Doz.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

ECP-LUTX V 3.0

Identifier Type: -

Identifier Source: org_study_id