drugset / Trial / NCT02181257
Extracorporeal Photopheresis for Medicare Recipients of Lung Allografts
Phase 3
Active not recruiting
280 enrolled
Washington University School of Medicine
Centers for Medicare and Medicaid Services/ Coverage and Analysis Group · collabThe Foundation for Barnes-Jewish Hospital · collabTherakos · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2027-04
- Completion
- 2028-12
Publications
- Background Burton CM, Carlsen J, Mortensen J, Andersen CB, Milman N, Iversen M. Long-term survival after lung transplantation depends on development and severity of bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2007 Jul;26(7):681-6. doi: 10.1016/j.healun.2007.04.004.
- Background Hadjiliadis D, Steele MP, Govert JA, Davis RD, Palmer SM. Outcome of lung transplant patients admitted to the medical ICU. Chest. 2004 Mar;125(3):1040-5. doi: 10.1378/chest.125.3.1040.
- Background Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR. The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.
- Results Reviewed in: Centers for Medicare and Medicaid Services. Final Decision Memorandum for Extracorporeal Photophresis (CAG-00324R), April 2012
- Chionis L, Grossman BJ, Hachem R, Commean P, Derfler MC, Vedantham S, Dodds K, Spitznagel E, Atkinson J, Despotis G. The efficacy of extracorporeal photopheresis to arrest bronchiolitis obliterans in lung allograft recipients was compared between two automated photopheresis instruments. Transfusion. 2018 Dec;58(12):2933-2941. doi: 10.1111/trf.14913. Epub 2018 Oct 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Methoxsalen | Other / unclassified | — | — |