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Study identifier: NCT03459534 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

Condition: Chronic Myeloid Leukemia, Chronic Phase · CML, Chronic Phase · CML, Refractory  ·  Sponsor: Il-Yang Pharm. Co., Ltd.

PhasePhase 3
Planned participants173
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.

This description comes directly from the study's public registry record.

Talk to the study team

Na Yun Kim  ·  +82.70.7165.7316  ·  nykim@ilyang.co.kr

Kang Hi An  ·  +82.70.7165.7322  ·  khan@ilyang.co.kr

Always discuss trial participation with your own doctor first.

Locations (18)

Territorial State Budgetary InstitutionBarnaul, RussiaNot Yet Recruiting
Federal State Budgetary Institution of ScienceKirov, RussiaRecruiting
Federal State Budgetary InstitutionMoscow, RussiaNot Yet Recruiting
Hematology Centre based on City Clin. Hosp. n.a. S.P. BotkinMoscow, RussiaRecruiting
Federal State Budgetary InstitutionSaint Petersburg, RussiaRecruiting
Federal State Budgetary InstitutionSaint Petersburg, RussiaRecruiting
Uijeongbu Eulji Medical Center, Eulji UniversityUijeongbu-si, Gyeonggi-do, South KoreaRecruiting
Ankara University Medical FacultyAnkara, Turkey (Türkiye)Recruiting
Gazi University Medical FacultyAnkara, Turkey (Türkiye)Recruiting
Istanbul University Cerrahpasa - Cerrahpasa Medical FacultyIstanbul, Turkey (Türkiye)Recruiting
Ege University Medical FacultyIzmir, Turkey (Türkiye)Recruiting
Mersin University Medical FacultyMersin, Turkey (Türkiye)Recruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03459534