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

Phase 2

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: Radotinib

• Registration Number: NCT02422719
• Lead Sponsor: Ulsan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-05
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radotinib	Radotinib	Radotinib treatement single arm

Primary Outcome Measures

Name	Time	Method
Rate of Major cytogenetic response	by 12 months after radotinib treatment	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.

Secondary Outcome Measures

Name	Time	Method
Rate of Major Molecular response (MR3.0) on each time point	up to 12 months
The number of Participants with Adverse Events	12 months

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of