CTIS2024-511381-36-00招募中1 期
A phase IIIb, multi-center, open-label, treatment optimization study of oralasciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CMLCP)previously treated with 2 or more tyrosine kinase inhibitors - CABL001A2302
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 205
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study, 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, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2, Adequate end organ function (as per central laboratory tests)
排除标准
- •Known presence of the BCR-ABL1 T315I mutation at any time prior to study entry, Known second chronic phase of CML after previous progression to 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
研究者
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