Dose-escalation of second-line and first-line asciminib in chronic myeloid leukemia in chronic phase: the ASC2ESCALATE Phase II trial.

IF 3 4区 医学 Q2 ONCOLOGY
Ehab L Atallah, Michael J Mauro, Koji Sasaki, Moshe Y Levy, Paul Koller, Daisy Yang, Dramane Laine, John Sabo, Ennan Gu, Jorge E Cortes
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引用次数: 0

Abstract

Up to 40% of newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) discontinue treatment by 5 years, primarily due to resistance or intolerance. Rates of resistance to second-line (2L) treatment are also high. Some patients with resistance respond with dose escalation of tyrosine kinase inhibitors (TKIs). Asciminib demonstrated safety and efficacy across a broad dosage range. ASC2ESCALATE is an ongoing, Phase II, multicenter, single-arm, dose-escalation study of asciminib in 2L and first-line treatment of CML-CP. The primary end point is major molecular response at 12 months in 2L. Secondary end points include molecular responses at and by scheduled time points, survival, and safety. ASC2ESCALATE is the first study investigating asciminib in CML-CP following failure of one prior TKI.Clinical Trial Registration: NCT05384587 (ClinicalTrials.gov).

慢性髓性白血病慢性期二线和一线阿西米尼的剂量递增:ASC2ESCALATE II 期试验。
在新确诊的慢性髓性白血病慢性期(CML-CP)患者中,高达 40% 的患者在 5 年内中断了治疗,主要原因是耐药或不耐受。二线(2L)治疗的耐药率也很高。一些耐药患者会对酪氨酸激酶抑制剂(TKIs)的剂量升级产生反应。Asciminib在广泛的剂量范围内均表现出安全性和有效性。ASC2ESCALATE 是一项正在进行的 II 期、多中心、单臂、剂量递增研究,研究对象是阿西米尼用于 CML-CP 的 2L 和一线治疗。主要终点是 2L 治疗 12 个月时的主要分子反应。次要终点包括预定时间点的分子反应、存活率和安全性。ASC2ESCALATE 是首个研究 asciminib 在既往使用过一种 TKI 治疗失败的 CML-CP 患者中的应用:临床试验注册:NCT05384587(ClinicalTrials.gov)。
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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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