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

  • End date
    Apr 1, 2025
  • participants needed
  • sponsor
    Il-Yang Pharm. Co., Ltd.
Updated on 25 March 2022


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.

Condition Chronic Myeloid Leukemia, Chronic Phase, CML, Chronic Phase, CML, Refractory, CML - Philadelphia Chromosome
Treatment Radotinib, Radotinib HCl
Clinical Study IdentifierNCT03459534
SponsorIl-Yang Pharm. Co., Ltd.
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

Male or female patients aged 18 years old
Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib
ECOG scale 0, 1 or 2
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
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)
Women of childbearing potential should have a negative serum or urine pregnancy test
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
within 14 days of the enrollment

Exclusion Criteria

Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once
Patients with CCyR at the time of screening
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
Medical history of clinically confirmed myocardial infarction
Medical history of unstable angina (within last 12 months)
Other clinically significant cardiac disease
Patients with T315I point mutations
Pregnancy confirmed at screening pregnancy test
Patients with central nervous system involvement as cytopathologically confirmed
Severe or uncontrolled chronic disease
Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia
Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow
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
Patients who participated in other clinical study and are receiving any other IP
Patients who cannot give consent to the clinical study
Patients who have concurrently clinically significant primary malignancy
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
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
Gastrointestinal disorder or gastrointestinal disease that may result in a significant change in the absorption of the investigational product
Medical history of acute or chronic pancreatitis within the past one year
Acute or chronic liver, pancreas, or severe kidney disease that are not associated with the disease
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
Women patients that meet the following conditions should be excluded from the clinical study
Women of childbearing potential who is unwilling to use an appropriate method of contraception during the study
Men patients who are unwilling to use and appropriate method of contraception during
the study
Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product
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