For Healthcare Professionals

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

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About the 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.
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Who can take part

You may be eligible to participate in the study if you meet the following 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.
  5. Blast in peripheral blood and bone marrow <15%
  6. The sum of blast and promyelocyte in peripheral blood and bone marrow <30%
  7. Basophil in peripheral blood <20%
  8. Platelets count ≥50 × 10^9/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia [< 50 × 109/L (< 50,000/mm3)] is acceptable
  9. No evidence of involvement of extramedullary leukemia other than enlargements of liver and spleen
  10. Patients who have adequate organ functions as defined below:
  11. Total bilirubin < 1.5 × upper limit of normal (ULN)
  12. SGOT and SGPT < 2.5× ULN
  13. Creatinine < 1.5 × ULN
  14. Serum amylase and lipase ≤ 1.5 × ULN
  15. Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)
  16. Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.
  17. 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:
  4. LVEF <45% or < lower bound of normal limit of study site (whichever higher), confirmed by echocardiogram at the site
  5. Patients who cannot have QT intervals measured according to ECG
  6. Complete left bundle branch block
  7. Patients with cardiac pacemakers
  8. Patients with congenital long QT syndrome or the family history of known long QT syndrome
  9. History of, or presence of symptomatic ventricular or atrial tachyarrhythmias
  10. Clinically significant resting bradycardia (< 50 bpm)
  11. 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.
  12. Medical history of clinically confirmed myocardial infarction
  13. Medical history of unstable angina (within last 12 months)
  14. Other clinically significant cardiac disease
  15. Patients with T315I point mutations
  16. Patients with central nervous system involvement as cytopathologically confirmed
  17. Severe or uncontrolled chronic disease
  18. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia
  19. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow
  20. 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.
  21. Patients who participated in other clinical study and are receiving any other IP.
  22. Patients who cannot give consent to the clinical study.
  23. Patients who have concurrently clinically significant primary malignancy
  24. 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.
  25. 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.
  26. Gastrointestinal disorder or gastrointestinal disease that may result in a significant change in the absorption of the investigational product
  27. Medical history of acute or chronic pancreatitis within the past one year
  28. Acute or chronic liver, pancreas, or severe kidney disease that are not associated with the disease
  29. 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.
  30. Women patients that meet the following conditions should be excluded from the clinical study.
  31. Pregnancy
  32. Breastfeeding
  33. Pregnancy confirmed at screening pregnancy test
  34. Women of childbearing potential who is unwilling to use an appropriate method of contraception during the study
  35. Men patients who are unwilling to use and appropriate method of contraception during the study
  36. Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +82.70.7165.7316Email iconEmail Study Center

Study’s details


Contition

CML - Philadelphia Chromosome,CML, Chronic Phase,CML, Refractory,Chronic Myeloid Leukemia, Chronic Phase,Leukemia, Myeloid, Chronic Phase

Age (in years)

18 - 200

Phase

Phase 3

Participants needed

173

Est. Completion Date

Apr 2025

Treatment type

Interventional


Sponsor

Il-Yang Pharm. Co., Ltd.

ClinicalTrials.gov identifier

NCT03459534

Study number

RT51KRI03

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