Extracorporeal Photopheresis (ECP) After Lung Transplantation

NCT05721079 | Completed DMC

• 1 other identifier: ECP-LUTX V 3.0
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Infection; Lung Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD

  24 months

Secondary Outcomes (8)

• Frequency of ACR and of lymphocytic bronchiolitis (LB)

  24 months

• Incidence of clinically treated infections

  24 months

• Detection of plasma CMV DNA

  24 months

• Patient survival

  36 months

• Graft survival

  36 months

Study Arms (2)

ECP with standard triple IS

EXPERIMENTAL

Device: ECP (Extracorporeal Photopheresis System)

standard triple IS

ACTIVE COMPARATOR

Device: ECP (Extracorporeal Photopheresis System)

Interventions

ECP (Extracorporeal Photopheresis System) 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.

Also known as: 8-Methoxypsoralen

ECP with standard triple IS; standard triple IS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz.Dr.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available for the next 6 months

Locations

AU (1)