Radotinib as 3rd or Later Line Therapy in CP-CML

Radotinib Efficacy and Safety Validation in Chronic Phase Chronic Myeloid Leukemia Patients Who Are Intolerant or Resistant to at Least Two Tyrosine Kinase Inhibitors As a Third or Subsequent Line Therapy

The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.

Inclusion Criteria:

• Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs).
• ECOG 0, 1, 2
• Patients who are agree and signed to informed consent.

Exclusion Criteria:

• T315I mutation
• Prior exposure to radotinib
• Accelerated or blastic phase
• galactose intolerance, severe lactase deficiency or glucose galactose malabsorption
• Prior history of intensive cytotoxic chemotherapy except for TKIs
• Significant cardiac problem
• QTcF > 450 msec
• Pancreatitis history prior to study enrollment
• Clinically significant malignant disease other than CML
• Pregnant or breast feeding woman