テルイ　ヤスヒト   TERUI Yasuhito   照井　康仁    所属   埼玉医科大学  医学部 血液内科    職種   教授
論文種別	学術雑誌(原著)
言語種別	英語
査読の有無	査読あり
表題	Phase 1/2 study of venetoclax, a BCL-2 inhibitor, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma
掲載誌名	正式名：Int J Hematol ISSNコード：18653774
掲載区分	国外
巻・号・頁	113,370-380頁
著者・共著者	Izutsu, K., Yamamoto, K., Kato, K., Ishikawa, T., Fukuhara, N., Terui, Y., Choi, I., Humphrey, K., Kim, S. Y., Okubo, S., Ogawa, N., Nishimura, Y., Salem, A. H., Maruyama, D.
発行年月	2021
概要	Venetoclax is a potent BCL-2 inhibitor that induces apoptosis in CLL cells. This open-label, phase 1/2 study evaluated the safety, pharmacokinetics, and efficacy of venetoclax in Japanese patients with R/R CLL/SLL. Patients enrolled in phase 1 received 400 mg/day venetoclax monotherapy. Patients enrolled in phase 2 received 400 mg/day venetoclax, plus rituximab. Venetoclax was administered with a weekly stepwise ramp-up in doses. In phase 2, efficacy was evaluated by objective response rate (ORR). Twelve patients were enrolled, six in each arm. The most common grade ≥ 3 adverse events were neutropenia (83%), lymphopenia (67%), leukopenia (33%), and thrombocytopenia (17%). Patients receiving venetoclax monotherapy achieved an ORR of 100%, including a complete remission (CR) rate of 17%. Patients receiving combination therapy had an ORR of 67% and a CR rate of 50%.
DOI	10.1007/s12185-020-03024-3
文献番号	33094474