Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

Sakamaki H; Ishizawa K; Taniwaki M; Fujisawa S; Morishima Y; Tobinai K; Okada M; Ando K; Usui N; Miyawaki S; Utsunomiya A; Uoshima N; Nagai T; Naoe T; Motoji T; Jinnai I; Tanimoto M; Miyazaki Y; Ohnishi K; Iida S; Okamoto S; Seriu T; Ohno R

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Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

机译：达沙替尼在日本慢性粒细胞白血病或费城染色体阳性急性淋巴细胞白血病患者中的1/2期临床研究。

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A phase 1/2 study was conducted to assess the safety and efficacy of dasatinib in Japanese patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) resistant or intolerant to imatinib. In phase 1, 18 patients with chronic phase (CP) CML were treated with dasatinib 50, 70, or 90 mg twice daily to evaluate safety. Dasatinib

机译：进行了一项1/2期研究，评估了dasatinib在对伊马替尼耐药或不耐受的慢性骨髓性白血病（CML）或费城染色体阳性急性淋巴细胞白血病（Ph（+）ALL）的日本患者中的安全性和有效性。在阶段1中，每天用50，70或90 mg达沙替尼治疗18例慢性期（CP）CML患者，以评估其安全性。每天两次达90毫克的达沙替尼具有良好的耐受性。在阶段2中，达沙替尼70 mg每天两次给予CP-CML患者24周，并给予处于加速期（AP）/高危（BC）或Ph（+）ALL的CML患者12周。在CP-CML组（n = 30）中，完全血液学应答为90％，主要细胞遗传学应答（MCyR）为53％。在AP / BC-CML组（n = 11）中，主要血液学反应（MaHR）为64％，MCyR为27％，而在Ph（+）ALL组（n = 13）中，MaHR为38％，MCyR为54％。达沙替尼的耐受性良好，大多数非血液学毒性为轻度或中度。达沙替尼疗法可导致较高的血液学和细胞遗传学应答率，提示达沙替尼有望成为对伊马替尼耐药或不耐受的日本CML和Ph（+）ALL患者的一种新疗法。

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来源
《International journal of hematology》 |2009年第3期|共10页
作者
Sakamaki H; Ishizawa K; Taniwaki M; Fujisawa S; Morishima Y; Tobinai K; Okada M; Ando K; Usui N; Miyawaki S; Utsunomiya A; Uoshima N; Nagai T; Naoe T; Motoji T; Jinnai I; Tanimoto M; Miyazaki Y; Ohnishi K; Iida S; Okamoto S; Seriu T; Ohno R;
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正文语种 eng
中图分类血液疾病;
关键词
Adult; Aged; Antineoplastic Agents; Asian Continental Ancestry Group; Fusion Proteins; bcr-abl; Humans; Leukemia; Myeloid; Chronic-Phase; Middle Aged; Mutation; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pyrimidines; Thiazoles; *成年人; 老年人; 抗肿瘤药; 融合蛋白质类; BCR-ABL; 白血病; 髓样; 慢性期; 突变; 嘧啶类; 噻唑类;

机译：Adult;Aged;Antineoplastic Agents;Asian Continental Ancestry Group;Fusion Proteins;bcr-abl;Humans;Leukemia;Myeloid;Chronic-Phase;Middle Aged;Mutation;Precursor Cell Lymphoblastic Leukemia-Lymphoma;Pyrimidines;Thiazoles;*成年人;老年人;抗肿瘤药;融合蛋白质类;BCR-ABL;白血病;髓样;慢性期;突变;嘧啶类;噻唑类;

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专利

1. Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. [J] . Sakamaki H, Ishizawa K, Taniwaki M, International journal of hematology . 2009,第3期

机译：达沙替尼在日本慢性粒细胞白血病或费城染色体阳性急性淋巴细胞白血病患者中的1/2期临床研究。
2. Dasatinib: in chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. [J] . Keam SJ BioDrugs: Clinical immunotherapeutics, biopharmaceuticals, and gene therapy . 2008,第1期

机译：达沙替尼：在慢性粒细胞白血病和费城染色体阳性的急性淋巴细胞白血病中。
3. First report of phase 2 study of dasatinib with hyper-CVAD for the frontline treatment of patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. [J] . Ravandi F, OBrien S, Thomas D, Blood: The Journal of the American Society of Hematology . 2010,第12期

机译：达沙替尼与超CVAD联合用于费城染色体阳性（Ph +）急性淋巴细胞白血病患者的一线治疗的第二阶段研究的第一份报告。
4. Optimizing the Classification of Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia Samples using Artificial Neural Networks [C] . Nuannuan Zong, Malek Adjouadi, Melvin Ayala Annual Rocky Mountain Bioengineering Symposium . 2006

机译：利用人工神经网络优化急性淋巴细胞白血病和急性髓性白血病样品的分类
5. Prognostic factors in patients with Philadelphia chromosome positive acute lymphoblastic leukemia. [D] . Faccuseh, Maria. 1999

机译：费城染色体阳性的急性淋巴细胞白血病患者的预后因素。
6. A phase I study of danusertib (PHA-739358) in adult patients with accelerated or blastic phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant or intolerant to imatinib and/or other second generation c-ABL therapy [O] . Gautam Borthakur, Herve Dombret, Philippe Schafhausen, 2015

机译：danusertib（PHA-739358）在患有伊马替尼和/或其他第二代c-ABL治疗耐药或不耐伊马替尼的成年期或加速期慢性髓样白血病和费城染色体阳性急性淋巴细胞白血病的成年患者中进行的一项I期研究
7. A phase I study of danusertib (PHA-739358) in adult patients with accelerated or blastic phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant or intolerant to imatinib and/or other second generation c-ABL therapy [O] . Borthakur, Gautam, Dombret, Herve, Kantarjian, Hagop, 2015

机译：danusertib（PHA-739358）在患有伊马替尼和/或其他第二代c-ABL治疗耐药或不耐伊马替尼的成年期或成年期慢性髓样白血病和费城染色体阳性急性淋巴细胞白血病的成年患者中进行的一项I期研究

Phase 1/2 clinical study of dasatinib in Japanese patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

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