Final results of a randomized, phase III study of rituximab with or without idelalisib followed by open-label idelalisib in patients with relapsed chronic lymphocytic leukemia
Journal of Clinical Oncology Apr 25, 2019
Sharman JP, et al. - Given that the observed superior effectiveness of the idelalisib (IDELA)-plus-rituximab (IDELA/R) arm led to early cessation of a randomized, double-blind, phase 3 study of IDELA plus rituximab vs placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL), and an extension study was performed with patients in either arm who were then given IDELA monotherapy, researchers describe the long-term effectiveness and safety data for IDELA-treated patients across the primary and extension studies. In a random manner, they assigned 110 patients to receive rituximab in combination with IDELA 150 mg twice daily (IDELA/R) or placebo (placebo/R; n = 110). They observed improved progression-free survival and overall survival with IDELA vs rituximab monotherapy in patients with relapsed CLL. With an expected safety profile, IDELA demonstrated effectiveness when administered over a long duration. With longer exposure, they found no new IDELA-related adverse events.
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