Can a new pill rescue patients when standard leukemia drugs stop working?

NCT ID NCT03459534

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 173 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2018

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

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.

  1. The places running it

    18 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ankara University Medical Faculty

    RECRUITING

    Ankara, Turkey (Türkiye)

  • CI Cherkasy Regional Oncological Dispensary of CRC

    RECRUITING

    Cherkassy, Ukraine

  • CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC

    RECRUITING

    Dnipro, Ukraine

  • CTPI Chernihiv Regional Oncological Dispensary

    RECRUITING

    Chernihiv, Ukraine

  • Ege University Medical Faculty

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Federal State Budgetary Institution

    NOT_YET_RECRUITING

    Moscow, 125167, Russia

  • Federal State Budgetary Institution

    RECRUITING

    Saint Petersburg, 191024, Russia

  • Federal State Budgetary Institution

    RECRUITING

    Saint Petersburg, 197341, Russia

  • Federal State Budgetary Institution of Science

    RECRUITING

    Kirov, 610027, Russia

  • Gazi University Medical Faculty

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Hematology Centre based on City Clin. Hosp. n.a. S.P. Botkin

    RECRUITING

    Moscow, 300186883, Russia

  • Institute of CR of SI NSC of Radiation Medicine of NAMSU H&T Unit

    RECRUITING

    Kyiv, Ukraine

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Mersin University Medical Faculty

    RECRUITING

    Mersin, Turkey (Türkiye)

  • Ondokuz Mayis Univ. Med. Fac.

    RECRUITING

    Samsun, Turkey (Türkiye)

  • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

    RECRUITING

    Lviv, Ukraine

  • Territorial State Budgetary Institution

    NOT_YET_RECRUITING

    Barnaul, 656024, Russia

  • Uijeongbu Eulji Medical Center, Eulji University

    RECRUITING

    Uijeongbu-si, Gyeonggi-do, 11749, South Korea

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