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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: Radotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radotinib<br>Radotinib treatement single arm | Drug: Radotinib<br>* Radotinib 400mg bid<br>* Other names: Supect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate 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. | by 12 months after radotinib treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Molecular response (MR3.0) on each time point |  | up to 12 months | 
| The number of Participants with Adverse Events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myeloid leukemia, Intolerance, Resitance, Radotinib