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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Radotinib 400mg bid
Ulsan University Hospital
Ulsan, South Korea
RECRUITINGRate of Major cytogenetic response
The rate of achieving major cytogenetic response \[35% or less t(9;22) chromosome by conventional banding technique\] in bone marrow by 12 months after radotinib treatment will be the primary end point.
Time frame: by 12 months after radotinib treatment
Rate of Major Molecular response (MR3.0) on each time point
Time frame: up to 12 months
The number of Participants with Adverse Events
Time frame: 12 months
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