NCT07604064招募中2 期
A Phase II Clinical Trial of Olutasidenib in Patients With Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3
- 试验地点
- 1
研究概览
简要总结
This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients who personally provide written informed consent to participate in this clinical trial
- •Patients with a confirmed diagnosis of AML based on WHO classification (2022 edition) (except acute promyelocytic leukemia with t (15:17) translocation)
- •Patients with relapsed or refractory AML who may or may not have undergone allogeneic hematopoietic stem cell transplantation.
- •Patients with IDH1 gene mutation confirmed by central confirmation after relapse or refractoriness
排除标准
- •Patients with IDH2 mutations or patients with a history of IDH2 inhibitor treatment
- •Patients who are intolerant to IDH1 inhibitors
- •Patients who are deemed inappropriate for the clinical trial by the investigator or sub-investigator
研究者
研究点 (1)
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