Extracorporeal photopheresis (ECP) in the treatment of chronic lung allograft dysfunction (CLAD): a prospective, multicentre, open-label, randomised controlled trial studying the addition of ECP to standard care in the treatment of bilateral lung transplant patients with CLAD (E-CLAD UK).
Fisher, A. J., et al.BMJ open respiratory research 2024; 11(1): 09.
Aims
The aim of this randomised controlled study protocol is to examine the effect of adding immunomodulatory therapy, in the form of extracorporeal photopheresis (ECP), to standard care in the treatment of chronic lung allograft dysfunction (CLAD).
Interventions
Participants will be randomised to receive ECP plus standard of care or standard of care alone.
Participants
90 bilateral lung transplant patients with CLAD.
Outcomes
The primary endpoint is lung function stabilisation. Th secondary endpoints include rate of decline in lung allograft function, exercise capacity, disease severity, health-related quality of life, adverse events and serious adverse events.
Follow-up
24 weeks from baseline at study entry.
CET Conclusions
This protocol describes the design of a multicentre, UK-based phase II study of extracorporeal photopheresis (ECP) in lung transplant recipients with chronic lung allograft dysfunction (CLAD). The authors aim to randomise 90 adult double-lung recipients with a new or existing diagnosis of CLAD to standard of care or ECP therapy using an experimental photosensitisation agent (methoxsalen) over a 20-week period. Primary endpoint is stabilisation of forced expiratory volume (FEV1) and forced vital capacity (FVC) from baseline to 12 and 24 months. The study opened to recruitment in February 2023 and is due to complete in 2025. The study is well described with stratified randomisation and clearly defined inclusion/exclusion criteria and endpoints. Assessment of response at 12 and 24 weeks will allow non-responders access to rescue therapies. The study also includes mechanistic and qualitative components, further enhancing its value.
Trial registration
EudraCT - 2022-002659-20; ISRCTN - 10615985.