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
Single group
Radotinib HCl
Drug1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd. 2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib) 3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder 4. Storage conditions: Store in an airtight light proof container at room temperature.
Major Cytogenetic Response (MCyR)
MCyR is defined as 0\~35% CCyR+PCyR based on ≥20 metaphase myelocytes. Chromosome test results from \<20 metaphase myelocytes will be excluded from the analysis.
Cytogenetic Response (CCyR)
CCyR is defined as complete loss of Ph chromosome based on ≥20 metaphase myelocytes. Chromosome test results from \<20 metaphase myelocytes will be excluded from the analysis.
Major molecular response
MMR is defined as a ≥3-log reduction in BCR-ABL1 transcript level from the standardized reference or BCR-ABL1/ABL % of ≤0.1% according to the international reference when the level of BCR-ABL1 gene was measured by RQ-PCR, a standardized quantitative genetic method.
Overall Survival(OS)
OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.
Progression Free Survival (PFS)
PFS is defined as the duration from the first day of Radotinib administration to the earliest day of disease progression or death for certain causes.
BCR-ABL1 point mutation
Incidence rate of BCR-ABL1 point mutations that are newly found during the course of radotinib treatment
correlation between the concentration of radotinib in blood and the response (efficacy and safety)
To measure the concentration of radotinib in blood
Incidence of Radotinib-Adverse Events
Toxicities will be evaluated in all subjects treated with radotinib.
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