jRCT2011240057招募中不适用
A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.>=18 years of age at the time of signing the informed consent
- •3.BCR:ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
- •4.Prior bone marrow transplant allowed if >=6 months prior to the first dose of ELVN-001
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •6.Screening laboratory values must meet the required criteria within 3 days prior to the first dose of ELVN-001
排除标准
- •1.Uncontrolled cardiovascular condition, including ongoing cardiac arrythmias, congestive heart failure, angina, or myocardial infarction within the past 3 months
- •2.History of another active malignancy within 2 years prior to study entry except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
- •3.History of acute TKI-related pancreatitis within 6 months of study entry; or active chronic pancreatitis or pancreatic disease due to any cause
- •4.Acute or chronic liver disease
研究者
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