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

ovartis Pharma AG0 个研究点目标入组 186 人开始时间: 2021年7月26日最近更新: 2024年8月5日

研究概览

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•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

•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
•Participation in a prior investigational study within 30 days prior to randomization or
•within 5-half-lives of the investigational product, whichever is longer.
•Other protocol defined exclusion criteria may apply

发起方