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
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovartis
- 入组人数
- 2
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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 .
结局指标
主要结局
未指定
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