Can a new pill rescue patients when standard leukemia drugs stop working?
NCT ID NCT03459534
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase 3 trial tests the drug radotinib in adults with chronic-phase chronic myeloid leukemia (CML) who have not responded to or could not tolerate earlier treatments such as imatinib. Participants take radotinib twice daily, and researchers measure how well it reduces leukemia cells in the bone marrow and blood. The goal is to see if radotinib can control the disease in this harder-to-treat group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radotinib (a tyrosine kinase inhibitor, brand name Supect)
- What this could lead to
- If it works, radotinib could offer a new treatment option for people with chronic myeloid leukemia who have not responded to or cannot tolerate other TKIs like imatinib.
- What could go wrong
- This is a single-arm trial without a comparison group, so results may be less definitive. Radotinib may cause side effects, and not all patients may respond.
Why investors are watching
Il-Yang Pharm is running a phase 3 trial of its drug radotinib in 173 patients with chronic myeloid leukemia who failed or cannot tolerate earlier treatments like imatinib. For a small company, this single trial is a major part of its pipeline, so the outcome will directly affect its future prospects.
If it works: If radotinib shows good efficacy and safety in this difficult-to-treat group, Il-Yang could gain a new approved use for the drug in multiple countries. That could expand its market and strengthen its position as a maker of cancer medicines.
If it fails: Phase 3 trials often fail to meet their goals, and this one has no comparison group, so results can be hard to interpret. A failure or delay would leave Il-Yang without a key growth driver and could hurt its credibility with doctors and partners.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 173 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2018
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ankara University Medical Faculty
RECRUITINGAnkara, Turkey (Türkiye)
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CI Cherkasy Regional Oncological Dispensary of CRC
RECRUITINGCherkassy, Ukraine
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CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
RECRUITINGDnipro, Ukraine
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CTPI Chernihiv Regional Oncological Dispensary
RECRUITINGChernihiv, Ukraine
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Ege University Medical Faculty
RECRUITINGIzmir, Turkey (Türkiye)
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Federal State Budgetary Institution
NOT_YET_RECRUITINGMoscow, 125167, Russia
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Federal State Budgetary Institution
RECRUITINGSaint Petersburg, 191024, Russia
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Federal State Budgetary Institution
RECRUITINGSaint Petersburg, 197341, Russia
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Federal State Budgetary Institution of Science
RECRUITINGKirov, 610027, Russia
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Gazi University Medical Faculty
RECRUITINGAnkara, Turkey (Türkiye)
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Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin
RECRUITINGMoscow, 300186883, Russia
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Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit
RECRUITINGKyiv, Ukraine
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Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
RECRUITINGIstanbul, Turkey (Türkiye)
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Mersin University Medical Faculty
RECRUITINGMersin, Turkey (Türkiye)
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Ondokuz Mayis Univ. Med. Fac.
RECRUITINGSamsun, Turkey (Türkiye)
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SI Institute of Blood Pathology and Transfusion Medicine of AMSU
RECRUITINGLviv, Ukraine
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Territorial State Budgetary Institution
NOT_YET_RECRUITINGBarnaul, 656024, Russia
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Uijeongbu Eulji Medical Center, Eulji University
RECRUITINGUijeongbu-si, Gyeonggi-do, 11749, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Real-World check: Asciminib's performance in Tough-to-Treat CML
- Last-Resort leukemia drug made available to 29 patients
- Leukemia patients who failed stopping meds may get another shot at drug-free remission
- New CML drug combo strategy aims for deeper remission without lifelong side effects
- New daily pill shows promise for Hard-to-Treat leukemia