{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T23:19:31Z","timestamp":1773011971145,"version":"3.50.1"},"reference-count":41,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T00:00:00Z","timestamp":1620604800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>The standard of care for indolent non\u2010Hodgkin lymphoma (iNHL) is rituximab, an anti\u2010CD20 antibody, with\/without chemotherapy. However, multiple relapses are common in these patients. This phase 3, randomized study compared outcomes of a combination of ofatumumab (a second\u2010generation anti\u2010CD20 antibody) and bendamustine, with bendamustine alone in patients unresponsive to prior rituximab\u2010based treatment. Overall, 346 patients were randomized to receive either the combination or bendamustine alone. Bendamustine was given for \u22648 cycles and ofatumumab for \u226412 cycles. The primary end\u2010point was progression\u2010free survival (PFS) after 215 protocol\u2010defined events assessed by independent review committee (IRC). Median IRC\u2010assessed PFS was 16\u00b77 and 13\u00b78\u00a0months in the combination and monotherapy arms respectively [hazard ratio (HR)\u00a0=\u00a00\u00b782; <jats:italic>P<\/jats:italic>\u00a0=\u00a00\u00b71390]. Median overall survival (OS) was 58\u00b72 and 51\u00b78\u00a0months in the combination and monotherapy arms respectively (HR\u00a0=\u00a00\u00b789, <jats:italic>P<\/jats:italic>\u00a0=\u00a00\u00b74968). The safety profile was consistent with previous reports. Overall, 73% and 80% of patients in the combination and monotherapy arms, respectively, experienced a \u2265grade 3 adverse event. The study did not meet its primary end\u2010point. No significant improvement in PFS and OS was seen with the combination of ofatumumab and bendamustine as compared with bendamustine alone in rituximab\u2010refractory iNHL (NCT01077518).<\/jats:p>","DOI":"10.1111\/bjh.17420","type":"journal-article","created":{"date-parts":[[2021,5,11]],"date-time":"2021-05-11T06:51:39Z","timestamp":1620715899000},"page":"1123-1133","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab\u2010refractory iNHL (COMPLEMENT A\u00a0+\u00a0B study)"],"prefix":"10.1111","volume":"193","author":[{"given":"Mathias J.","family":"Rummel","sequence":"first","affiliation":[{"name":"Department for Haematology Clinic for Haematology and Medical Oncology Justus\u2010Liebig University\u2010Hospital Gie\u00dfen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann","family":"Janssens","sequence":"additional","affiliation":[{"name":"Department of Haematology Universitaire Ziekenhuizen Leuven Leuven Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"MacDonald","sequence":"additional","affiliation":[{"name":"Division of Haematology Dalhousie University Halifax NS Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary\u2010Margaret","family":"Keating","sequence":"additional","affiliation":[{"name":"Division of Haematology Dalhousie University Halifax NS Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan M.","family":"Zaucha","sequence":"additional","affiliation":[{"name":"Department of Haematology and Transplantology Medical University of Gda\u0144sk Gda\u0144sk Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaclyn","family":"Davis","sequence":"additional","affiliation":[{"name":"Novartis Oncology East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet","family":"Lasher","sequence":"additional","affiliation":[{"name":"Novartis Oncology East Hanover NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chaitali","family":"Babanrao Pisal","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt. 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