A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib
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.
‣ Blast in peripheral blood and bone marrow \<15%
⁃ The sum of blast and promyelocyte in peripheral blood and bone marrow \<30%
⁃ Basophil in peripheral blood \<20%
⁃ Platelets count ≥50 × 10\^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia \[\< 50 × 109/L (\< 50,000/mm3)\] is acceptable
⁃ No evidence of involvement of extramedullary leukemia other than enlargements of liver and spleen
• Patients who have adequate organ functions as defined below:
‣ Total bilirubin \< 1.5 × upper limit of normal (ULN)
⁃ SGOT and SGPT \< 2.5× ULN
⁃ Creatinine \< 1.5 × ULN
⁃ Serum amylase and lipase ≤ 1.5 × ULN
⁃ Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)
• Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.