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Efficacy and safety of Radotinib for chronic myeloid leukemia patients who failed previous treatments

A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib

Phase 3 Interventional Il-Yang Pharm. Co., Ltd. · NCT03459534

This study is testing if Radotinib can help people with chronic myeloid leukemia who haven't had success with other treatments feel better and stay safe while using it.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment173 (estimated)
Ages18 Years and up
SexAll
SponsorIl-Yang Pharm. Co., Ltd. Industry-sponsored
Drugs / interventionsImatinib, Radotinib
Locations18 sites (Barnaul and 17 other locations)
Trial IDNCT03459534 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) who have either failed or are intolerant to previous tyrosine kinase inhibitor (TKI) therapies, including Imatinib. The study aims to enroll 173 participants in a single-arm design, administering Radotinib at a dose of 400mg twice daily. The trial will assess the treatment's effectiveness and safety profile in this specific patient population over the course of the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic phase Ph+ CML who have experienced failure or intolerance to previous TKI treatments.

Not a fit: Patients with acute phase CML or those who have not previously received TKI therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for CP-CML patients who have not responded to or cannot tolerate existing therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating CP-CML, indicating potential for success with Radotinib.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female patients aged 18 years old
2. Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
3. ECOG scale 0, 1 or 2
4. Chronic phase is defined as all of the following conditions that subjects meet.

   * Blast in peripheral blood and bone marrow \<15%
   * The sum of blast and promyelocyte in peripheral blood and bone marrow \<30%
   * Basophil in peripheral blood \<20%
   * Platelets count ≥50 × 10\^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia \[\< 50 × 109/L (\< 50,000/mm3)\] is acceptable
   * No evidence of involvement of extramedullary leukemia other than enlargements of liver and spleen
5. Patients who have adequate organ functions as defined below:

   * Total bilirubin \< 1.5 × upper limit of normal (ULN)
   * SGOT and SGPT \< 2.5× ULN
   * Creatinine \< 1.5 × ULN
   * Serum amylase and lipase ≤ 1.5 × ULN
   * Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)
6. Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.
7. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

1. Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.
2. Patients with CCyR at the time of screening
3. Any below impaired cardiac function:

   * LVEF \<45% or \< lower bound of normal limit of study site (whichever higher), confirmed by echocardiogram at the site
   * Patients who cannot have QT intervals measured according to ECG
   * Complete left bundle branch block
   * Patients with cardiac pacemakers
   * Patients with congenital long QT syndrome or the family history of known long QT syndrome
   * History of, or presence of symptomatic ventricular or atrial tachyarrhythmias
   * Clinically significant resting bradycardia (\< 50 bpm)
   * The mean QTcF \>450msec following three consecutive ECG tests at baseline

     : Screening test will be performed again for QTcF after the adjustment of electrolyte if QTcF \>450msec and the electrolyte is not within the normal range.
   * Medical history of clinically confirmed myocardial infarction
   * Medical history of unstable angina (within last 12 months)
   * Other clinically significant cardiac disease
4. Patients with T315I point mutations
5. Patients with central nervous system involvement as cytopathologically confirmed
6. Severe or uncontrolled chronic disease
7. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia
8. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow
9. Patients who received the major surgery within 4 weeks before the initiation of the IP administration or who failed to recover from the surgery that was performed before then.
10. Patients who participated in other clinical study and are receiving any other IP.
11. Patients who cannot give consent to the clinical study.
12. Patients who have concurrently clinically significant primary malignancy
13. Patients currently receiving treatment with a strong CYP3A4 inhibitors or strong CYP3A4 inducers or therapeutic Cumarin derivatives and that can neither stop the administration of these drugs before the start of the IP administration nor switch to other drugs.
14. Patients who are currently receiving treatment with a medication that has the potential to prolong QT intervals and can neither stop the administration of the drugs before the start of the IP administration nor switch to other drugs. If subjects need to start such drug treatments during the study, they should contact the sponsor, IL-YANG PHARM. Co., Ltd.
15. Gastrointestinal disorder or gastrointestinal disease that may result in a significant change in the absorption of the investigational product
16. Medical history of acute or chronic pancreatitis within the past one year
17. Acute or chronic liver, pancreas, or severe kidney disease that are not associated with the disease
18. Patients known seropositive to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, or cirrhosis. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \< 500 IU/mL or site specific local lab normal range lower limit assessed by investigator), and cured hepatitis C patients can be enrolled.
19. Women patients that meet the following conditions should be excluded from the clinical study.

    * Pregnancy
    * Breastfeeding
    * Pregnancy confirmed at screening pregnancy test
    * Women of childbearing potential who is unwilling to use an appropriate method of contraception during the study
20. Men patients who are unwilling to use and appropriate method of contraception during the study
21. Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product

Where this trial is running

Barnaul and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myeloid Leukemia, Chronic PhaseCML, Chronic PhaseCML, RefractoryCML - Philadelphia Chromosome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.