A phase 2 study of BOsutinib Gradual Increase as a second or third line treatment for chronic myeloid leukemia in chronic phase - BOGI Trial

Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University0 个研究点目标入组 35 人开始时间: 2018年4月18日最近更新: 2024年9月2日

研究概览

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•1)Patients who have history of taking anti-cancer drugs other than hydroxyurea for CML 2)Patients who are newly diagnosed CML 3)Patients who have progress to AP or BP 4)Patients with severe or uncontrollable complications 5)Patients with complications of inflammatory bowel disease 6)Pregnant and breastfeeding women, patients who wish to get pregnant within 12 months 7)Patients who are participating in another clinical trial 8)Patients with known T315I or V299L mutation 9)Concomitant medications known to be strong inducers or inhibitors of P450 isoenzyme CYP3A4 10)Known HIV and/or active viral hepatitis (hepatitis B or C) 11)Impaired cardiac function, including any of the following: a. History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemiblock, bifascicular block in screening ECG b. ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads in screening ECG c. Congenital long QT syndrome d. QTc > 450 msec in the screening ECG e. QT-prolonging concomitant medication f. History of or presence of significant ventricular or atrial tachyarrhythmias in screening ECG g. Myocardial infarction within 6 months prior to inclusion h. Unstable angina diagnosed or treated during the past 12 months i. uncontrolled hypertension, history of labile hypertension

发起方

Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University