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Given the 58% response rate (1996 NCI\u2010WG criteria) of single agent ofatumumab in CLL refractory to fludarabine and alemtuzumab, we initiated a phase II trial examining response, safety, and progression\u2010free survival (PFS) of ofatumumab as front\u2010line monotherapy. Patients enrolled included untreated, symptomatic CLL patients over the age of 65 or those who were inappropriate\/did not desire chemotherapy. Two cohorts were enrolled sequentially examining either 1 g (33 patients) or 2 g (44 patients) weekly for 8 weeks followed by maintenance dosing every 2 months for a total of 24 months. Patients receiving 1 g were older than those receiving 2 g, but there were no significant differences in other clinical characteristics. The best overall response rates in the 1 and 2 g patient cohorts were 72 and 89% (1996 NCI\u2010WG criteria), respectively (54 and 68%, respectively, using 2008 IWCLL criteria). All but two responses were partial. The 24\u2010month estimated PFS rates were 46 and 78%, respectively. Response and PFS was lower in del(17p) and del(11q) CLL patients. Differences in PFS between dose cohorts were statistically significant and remained so when adjusting for age or high\u2010risk cytogenetics. Toxicity of this treatment was mild with only six patients not completing therapy due to toxicity. Ofatumumab induction followed by maintenance therapy in untreated CLL represents a well\u2010tolerated and active regimen, particularly with the 2 g of ofatumumab. Am. J. Hematol. 91:1020\u20131025, 2016. \u00a9 2016 Wiley Periodicals, Inc.<\/jats:p>","DOI":"10.1002\/ajh.24468","type":"journal-article","created":{"date-parts":[[2016,7,7]],"date-time":"2016-07-07T23:03:03Z","timestamp":1467932583000},"page":"1020-1025","source":"Crossref","is-referenced-by-count":12,"title":["A phase II study of two dose levels of ofatumumab induction followed by maintenance therapy in symptomatic, previously untreated chronic lymphocytic leukemia"],"prefix":"10.1002","volume":"91","author":[{"given":"Ian W.","family":"Flinn","sequence":"first","affiliation":[{"name":"Sarah Cannon Research Institute Nashville Tennessee"},{"name":"Tennessee Oncology Nashville Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy S.","family":"Ruppert","sequence":"additional","affiliation":[{"name":"Division of Hematology and Comprehensive Cancer Center at the Ohio State University Columbus Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Harwin","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute Nashville Tennessee"},{"name":"Florida Cancer Specialists Ft. 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