NL-OMON51998招募中3 期
A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase - CABL001J12301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients with newly (< 3 monhts) diagnosed CML-CP >= 18
- •years of age.
- •2. Diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome
- •3. ECOG performance status of 0, or 1.
- •4. Adequate end organ function
排除标准
- •1. Previous treatment of CML with any other anticancer agents including
- •chemotherapy and/or biologic agents or prior stem cell transplant
- •2. Known cytopathologically confirmed CNS infiltration.
- •3. Impaired cardiac function or cardiac repolarization abnormality
- •4. History of acute pancreatitis within 1 year of prior to randomization or
- •medical history of chronic
- •pancreatitis.
- •5. Pregnancy, lactation, insufficient contraception for females of
- •childbearing potential .
研究者
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