EUCTR2020-006057-21-IT进行中（未招募）1 期
A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase(CML-CP) previously treated with 2 or more tyrosine kinase inhibitors - CABL001A2302
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients with a diagnosis of CML-CP = 18 years of age Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib,
- •nilotinib, dasatinib, bosutinib, radotinib or ponatinib) Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening Adequate end organ function (as per central laboratory tests) Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •Known presence of the BCR-ABL1 T315I mutation at any time prior to
- •study entry
- •Known history of AP/BC
- •Previous treatment with a hematopoietic stem-cell transplantation
- •Patient planning to undergo allogeneic hematopoietic stem cell
- •transplantation
- •Uncontrolled cardiac repolarization abnormality
- •Severe and/or uncontrolled concurrent medical disease that in the
- •opinion of the investigator could cause unacceptable safety risks or
- •compromise compliance with the protocol
- •History of acute pancreatitis within 1 year of study entry or past medical
- •history of chronic pancreatitis
- •History of ongoing active acute or chronic liver disease
- •Other protocol defined exclusion criteria may apply
研究者
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