RT51KRI03 = Radotinib in Chronic Phase Chronic Myeloid Leukemia [Republic of Korea, Turkey, Ukraine]
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)
Indication and most important 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.
Short description of intervention
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.
Type of study
Trial after therapy failure or intolerance
Current status
Recruiting
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
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
Korea, Republic of
Seoul
The Catholic University of Korea, Seoul
St. Mary's Hospital
Principal Investigator: Dong-Wook Kim
Seoul, 0659
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