In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.
Male or female patients aged 18 years old
Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
ECOG scale 0, 1 or 2
Chronic phase is defined as all of the following conditions that subjects meet.
Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.
Patients with CCyR at the time of screening
LVEF <45% or < lower bound of normal limit of study site (whichever higher), confirmed by echocardiogram at the site
Patients who cannot have QT intervals measured according to ECG
Il-Yang Pharm. Co., Ltd.
Lead sponsor