Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts

The primary aims of this study is to determine the efficacy and tolerability of Extracorporeal Photopheresis (ECP) for the treatment of either Refractory Bronchiolitis Obliterans Syndrome (BOS) patients (258 at cessation of enrollment April 7, 2022) or Newly Diagnosed (22 as of enrollment Hold February 2022) Bronchiolitis Obliterans Syndrome patients after lung transplantation. In compliance with the Centers for Medicare and Medicaid Services' (CMS) Coverage with Evidence Development (CED) decision, the study will collect specified demographic, comorbidity, treatment, and outcome data exclusively for Medicare beneficiaries who are treated with ECP for either refractory or New BOS.

NCT Number	NCT02181257
Lead Sponsor	Washington University School of Medicine Collaborators: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group, Therakos, Inc, The Foundation for Barnes-Jewish Hospital
Conditions	Bronchiolitis Obliterans Syndrome (BOS)
Enrollment	280 participants
Start Date	2015-01
Primary Completion	2027-04 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-06