{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T19:59:10Z","timestamp":1774295950232,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,12,27]],"date-time":"2019-12-27T00:00:00Z","timestamp":1577404800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>PIX306 was a phase 3, randomised, single\u2010blind, multicentre trial conducted in adult patients with diffuse large B\u2010cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after \u22651 rituximab\u2010containing regimen and were not eligible for a stem cell transplant. Patients were randomised 1:1 to pixantrone 50\u00a0mg\/m<jats:sup>2<\/jats:sup> or gemcitabine 1000\u00a0mg\/m<jats:sup>2<\/jats:sup> on days 1, 8 and 15 of a 28\u2010day cycle, combined with rituximab 375\u00a0mg\/m<jats:sup>2<\/jats:sup> on day 1, for up to six cycles. Patients were followed for up to 96\u00a0weeks. The primary endpoint was progression\u2010free survival (PFS). Secondary endpoints included overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety. Overall, 312 patients were randomised (median age 73\u00b70\u00a0years). The study did not meet its primary endpoint. Median PFS [95% confidence interval (CI)] was 7\u00b73\u00a0months (5\u00b72\u20138\u00b74) with pixantrone\u00a0+\u00a0rituximab (PIX\u00a0+\u00a0R) and 6\u00b73\u00a0months (4\u00b74\u20138\u00b71) with gemcitabine\u00a0+\u00a0rituximab [GEM\u00a0+\u00a0R; hazard ratio (HR): 0\u00b785; 95% CI 0\u00b764\u20131\u00b714; <jats:italic>P<\/jats:italic>\u00a0=\u00a00\u00b728]. Median OS was 13\u00b73 (10\u00b71\u201319\u00b78) months with PIX\u00a0+\u00a0R and 19\u00b76 (12\u00b74\u201331\u00b79) months with GEM\u00a0+\u00a0R (HR: 1\u00b713; 95% CI 0\u00b783\u20131\u00b753). ORR was 61\u00b79% and 43\u00b79% respectively and CR rate 35\u00b75% and 21\u00b77%. The incidence of adverse events, including cardiac events, was not statistically significant different between PIX\u00a0+\u00a0R and GEM\u00a0+\u00a0R.<\/jats:p>","DOI":"10.1111\/bjh.16255","type":"journal-article","created":{"date-parts":[[2019,12,27]],"date-time":"2019-12-27T10:03:50Z","timestamp":1577441030000},"page":"240-248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B\u2010cell non\u2010Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306)"],"prefix":"10.1111","volume":"188","author":[{"given":"Ruth","family":"Pettengell","sequence":"first","affiliation":[{"name":"St. George's Hospital London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monika","family":"D\u0142ugosz\u2010Danecka","sequence":"additional","affiliation":[{"name":"Department of Haematology Jagiellonian University Krakow Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5699-4644","authenticated-orcid":false,"given":"David","family":"Andorsky","sequence":"additional","affiliation":[{"name":"Rocky Mountain Cancer Centers US Oncology Research Boulder CO USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Belada","sequence":"additional","affiliation":[{"name":"Clinical Haematology 4th Department of Internal Medicine Charles University, Hospital and Faculty of Medicine Hradec Kr\u00e1lov\u00e9 Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pencho","family":"Georgiev","sequence":"additional","affiliation":[{"name":"Clinic of Oncology and Haematology University Multiprofile Hospital for Active Treatment \"Sveti Georgi\" and Medical University Plovdiv Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald","family":"Quick","sequence":"additional","affiliation":[{"name":"Joe Arrington Cancer Research Treatment Center Lubbock TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack W.","family":"Singer","sequence":"additional","affiliation":[{"name":"CTI Biopharma Seattle WA USA"},{"name":"Elson S. 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