Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
Department of Oncology, Haematology and Bone Marrow Transplantation with section Pneumology, Hubertus Wald University Comprehensive Cancer Centre Hamburg, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Br J Haematol. 2018 Oct;183(2):235-241. doi: 10.1111/bjh.15546.
This open-label, multicentre phase I/II study determined the maximum tolerated dose (MTD), safety and efficacy of clofarabine administered with cytarabine and idarubicin in newly diagnosed acute myeloid leukaemia (AML) patients lacking favourable genetic aberrations. The MTD was 30 mg/m clofarabine for patients below and above 60 years. The most frequently reported grade 3-4 non-haematological adverse events were infectious and gastrointestinal toxicities. Complete remission (CR)/CR with incomplete recovery rate was 67%. Allogeneic haematopoietic cell transplantation in first remission was feasible in a high proportion of younger AML patients and probably contributed to the favourable outcome compared to historical controls.
本开放性、多中心的 I/II 期研究旨在确定在缺乏有利遗传异常的初诊急性髓系白血病（AML）患者中，用阿糖胞苷和伊达比星联合氯法拉滨治疗的最大耐受剂量（MTD）、安全性和疗效。60 岁以下和 60 岁以上患者的 MTD 分别为 30mg/m2 的氯法拉滨。最常报告的 3-4 级非血液学不良事件为感染和胃肠道毒性。完全缓解（CR）/不完全恢复的 CR 率为 67%。在年轻的 AML 患者中，大多数患者可行异基因造血细胞移植，这可能有助于获得与历史对照相比更好的结果。
