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10.1002/ajh.24468

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suck abstract from ncbi


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pmid27387131
      Am+J+Hematol 2016 ; 91 (10 ): 1020-5
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  • A phase II study of two dose levels of ofatumumab induction followed by maintenance therapy in symptomatic, previously untreated chronic lymphocytic leukemia #MMPMID27387131
  • Flinn IW ; Ruppert AS ; Harwin W ; Waterhouse D ; Papish S ; Jones JA ; Hainsworth J ; Byrd JC
  • Am J Hematol 2016[Oct]; 91 (10 ): 1020-5 PMID27387131 show ga
  • Despite the recent advances in treatment of CLL with targeted agents such as ibrutinib, availability of nonchemotherapy based therapies is desired. Given the 58% response rate (1996 NCI-WG criteria) of single agent ofatumumab in CLL refractory to fludarabine and alemtuzumab, we initiated a phase II trial examining response, safety, and progression-free survival (PFS) of ofatumumab as front-line 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-WG criteria), respectively (54 and 68%, respectively, using 2008 IWCLL criteria). All but two responses were partial. The 24-month 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-risk 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-tolerated and active regimen, particularly with the 2 g of ofatumumab. Am. J. Hematol. 91:1020-1025, 2016. © 2016 Wiley Periodicals, Inc.
  • |Age Factors [MESH]
  • |Aged [MESH]
  • |Aged, 80 and over [MESH]
  • |Antibodies, Monoclonal, Humanized [MESH]
  • |Antibodies, Monoclonal/*administration & dosage/adverse effects [MESH]
  • |Cytogenetics [MESH]
  • |Disease-Free Survival [MESH]
  • |Dose-Response Relationship, Drug [MESH]
  • |Female [MESH]
  • |Humans [MESH]
  • |Induction Chemotherapy [MESH]
  • |Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy [MESH]
  • |Maintenance Chemotherapy [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]


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