Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare Eligible Recipients of Lung Allografts

Human Clinical Study - The primary aims of this revised study are to determine the efficacy and tolerability of ECP for the treatment of either refractory (i.e., in an expanded series of patients within the origi-nal prospective cohort Registry, n=240) or new (i.e., in a new prospective randomized con-trolled trial sub-study, n=739) BOS after lung transplantation in a large patient series (total patients to be enrolled = 979). 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. This revised study will include no more than twenty (20) participating centers. Patients will be enrolled from CMS-approved lung transplant centers and other ECP therapy providers with appropriate expertise that agree in writing to comply with the protocol, secure Institutional Review Board (IRB) approval and complete the case report forms. The randomized controlled trial (RCT) component of the revised study that includes patients with an initial diagnosis of BOS, and will enable evaluation of potential survival and quality of life benefits of early treatment of BOS with first-line ECP.