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

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

Study participants will receive radotinib 400 mg twice daily for 12 months.

Key inclusion criteria

This study includes male or female patients who:

• are 18 years or older
• have been diagnosed with with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP)
• were previously treated with a tyrosine kinase inhibitor (TKI) including imatinib but did not respond to or tolerate treatment
• have adequate kidney and liver function.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.
• have a complete cytogenetic response (CCyR) at the time of screening
• have impaired heart function as defined in the study protocol
• have T315I point mutations.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

Korea, Republic of

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

Russia

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

Turkey

Ankara
Ankara University Medical Faculty
Principal Investigator: Muhit Ozcan

Ankara
Gazi University Medical Faculty
Principal Investigator: Munci Yagci

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

Izmir
Ege University Medical Faculty
Principal Investigator: Guray Saydam

Mersin
Mersin University Medical Faculty

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

Ukraine

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

Chernihiv
CTPI Chernihiv Regional Oncological Dispensary
Principal Investigator: Alla Nahorna

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

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

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