{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T01:40:52Z","timestamp":1789609252908,"version":"build-2803163510"},"reference-count":40,"publisher":"American Society of Hematology","issue":"14","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use. This phase 1\/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment. Adult patients with new-onset (\u22643 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A\/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT). Other outcomes included quality of life (QoL) measures and safety. Sixty patients were randomized; ITT included 53 patients (SoC+ECP: 29; SoC: 24). Week 28 ORR was 74.1% (SoC+ECP) and 60.9% (SoC). Investigator-assessed ORR was 56.0% (SoC+ECP) and 66.7% (SoC). Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients. Most frequent treatment-emergent adverse events (TEAEs) in SoC+ECP patients were hypertension (31.0%), cough (20.7%), dyspnea (17.2%), and fatigue (17.2%). Seventeen patients (SoC+ECP: 8; SoC: 9) experienced 35 serious adverse events (SAEs). No TEAEs or SAEs were considered related to the ECP instrument or methoxsalen. The encouraging short-term results of this study could inform the design of subsequent studies. This trial was registered at www.clinicaltrials.gov as #NCT01380535.<\/jats:p>","DOI":"10.1182\/bloodadvances.2019000145","type":"journal-article","created":{"date-parts":[[2019,7,22]],"date-time":"2019-07-22T16:55:14Z","timestamp":1563814514000},"page":"2218-2229","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":55,"title":["Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD"],"prefix":"10.1182","volume":"3","author":[{"given":"Madan","family":"Jagasia","sequence":"first","affiliation":[{"name":"Vanderbilt-Ingram Cancer Center, Nashville, TN;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof","family":"Scheid","sequence":"additional","affiliation":[{"name":"Stem Cell Transplantation Clinic I for Internal Medicine, University of Cologne, K\u00f6ln, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2114-7533","authenticated-orcid":false,"given":"G\u00e9rard","family":"Soci\u00e9","sequence":"additional","affiliation":[{"name":"APHP Hospital St. Louis, University Paris 7, Paris, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis Ayuketang","family":"Ayuk","sequence":"additional","affiliation":[{"name":"Department of Stem Cell Transplantation, Universit\u00e4etsklinikum Hamburg-Eppendorf, Hamburg, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johanna","family":"Tischer","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine III, University Hospital of Munich, Ludwig Maximilian University, Munich, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele L.","family":"Donato","sequence":"additional","affiliation":[{"name":"John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1rp\u00e1d","family":"B\u00e1tai","sequence":"additional","affiliation":[{"name":"Unified St. Istvan and St. Laszio Hospital, Budapest, Hungary;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heidi","family":"Chen","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5574-1434","authenticated-orcid":false,"given":"Sheau-Chiann","family":"Chen","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, TN;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Chin","sequence":"additional","affiliation":[{"name":"Mallinckrodt Pharmaceuticals, Bedminster, NJ; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henri","family":"Bood\u00e9e","sequence":"additional","affiliation":[{"name":"Mallinckrodt Pharmaceuticals, Bedminster, NJ; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0077-7464","authenticated-orcid":false,"given":"Ghaith","family":"Mitri","sequence":"additional","affiliation":[{"name":"Mallinckrodt Pharmaceuticals, Bedminster, NJ; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hildegard T.","family":"Greinix","sequence":"additional","affiliation":[{"name":"Division of Haematology, Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","published-online":{"date-parts":[[2019,7,22]]},"reference":[{"issue":"3","key":"2020021108171070300_B1","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1182\/blood-2017-03-775767","article-title":"An endpoint associated with clinical benefit after initial treatment of chronic graft-versus-host disease","volume":"130","author":"Martin","year":"2017","journal-title":"Blood"},{"issue":"11","key":"2020021108171070300_B2","doi-asserted-by":"crossref","first-page":"3214","DOI":"10.1182\/blood-2010-08-302109","article-title":"Comparative analysis of risk factors for acute graft-versus-host disease and for chronic graft-versus-host disease according to National Institutes of Health consensus criteria","volume":"117","author":"Flowers","year":"2011","journal-title":"Blood"},{"issue":"15","key":"2020021108171070300_B3","doi-asserted-by":"crossref","first-page":"3620","DOI":"10.1182\/blood-2008-07-168351","article-title":"Increased T-bet+ cytotoxic effectors and type I interferon-mediated processes in chronic graft-versus-host disease of the oral mucosa","volume":"113","author":"Imanguli","year":"2009","journal-title":"Blood"},{"issue":"26","key":"2020021108171070300_B4","doi-asserted-by":"crossref","first-page":"2565","DOI":"10.1056\/NEJMra1703472","article-title":"Pathophysiology of chronic graft-versus-host disease and therapeutic targets","volume":"377","author":"Zeiser","year":"2017","journal-title":"N Engl J Med"},{"issue":"2","key":"2020021108171070300_B5","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1016\/j.bbmt.2016.09.023","article-title":"The biology of chronic graft-versus-host disease: a task force report from the National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease","volume":"23","author":"Cooke","year":"2017","journal-title":"Biol Blood Marrow Transplant"},{"issue":"6","key":"2020021108171070300_B6","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1038\/nri3212","article-title":"Advances in graft-versus-host disease biology and therapy","volume":"12","author":"Blazar","year":"2012","journal-title":"Nat Rev Immunol"},{"issue":"3","key":"2020021108171070300_B7","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1016\/j.bbmt.2014.12.001","article-title":"National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. 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Published 2018. 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