RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Russia, Turkey, Ukraine]

Type of study

Trial after therapy failure or intolerance

Current status


Study title

Efficacy and Safety of Radotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase With Failure or Intolerance to Previous TKIs

Scientific title

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs (ClinicalTrials.gov no. NCT03459534)

What is the purpose of the study

This study is conducted to evaluate the efficacy and safety of radotinib 400 mg twice daily for 12 months in patients with Ph+ CML in chronic phase who did not respond or were intolerant to previous TKI therapy.

What will happen during the study

Key inclusion criteria

Male or female patients 18 years or older with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Patients can be considered for inclusion in the study if they were previously treated with a tyrosine kinase inhibitor (TKI) including imatinib but did not respond to or tolerate treatment. Kidney and liver function must be adequate

Other criteria may apply.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study sponsor

Il-Yang Pharm. Co., Ltd.

Scientific lead / contact

Hye Lin Park, Il-Yang Pharm. Co., Ltd.
Jeong Hye Kim, Il-Yang Pharm. Co., Ltd.

Principal investigator

Dong-Wook Kim, MD
The Catholic University of Korea’s St. Mary’s Hospital

Study centers / principal investigators

Korea, Republic of

Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si, Gyeonggi-do, 11749
Principal Investigator: Dong-Wook Kim
Seoul, 0659


Territorial State Budgetary Institution of Healthcare
Territorial Clinical Hospital
Barnaul, 656024
(not yet recruiting)

Federal State Budgetary Institution of Science
Kirov Scientific and Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency
Kirov, 610027

Federal State Budgetary Institution
Moscow, 125167
(not yet recruiting)

Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin
Moscow, 300186883

Federal State Budgetary Institution
Saint-Petersburg, 191024

Federal State Budgetary Institution
Saint-Petersburg, 197341


Ankara University Medical Faculty
Principal Investigator: Muhit Ozcan

Gazi University Medical Faculty
Principal Investigator: Munci Yagci

Istanbul University Cerrahpasa – Cerrahpasa Medical Faculty
Principal Investigator: Ahmet Eskazan

Ege University Medical Faculty
Principal Investigator: Guray Saydam

Mersin University Medical Faculty

Ondokuz Mayis Univ. Med. Fac.
Principal Investigator: Mehmet Turgut


CI Cherkasy Regional Oncological Dispensary of CRC
Principal Investigator: Halyna Pylypenko

CTPI Chernihiv Regional Oncological Dispensary
Principal Investigator: Alla Nahorna

CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
Principal Investigator: Anna Usenko

Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit
Principal Investigator: Iryna Dyagil

SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Principal Investigator: Zvenyslava Maslyak