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Chronic Myeloid Leukemia, Chronic PhasePhase 3NCT03459534

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

A Phase 3 study testing Radotinib HCl in people with Chronic Myeloid Leukemia, Chronic Phase and CML, Chronic Phase, run by Il-Yang Pharm. Co., Ltd. at 18 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radotinib HCl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
18 sitesin 4 countries
Study dates
25 Jun 2018to 30 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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 within 14 days of the enrollment.
  • 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.

Who cannot join

  • 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
Show all 37Show fewer
  • 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
  • Patients with T315I point mutations
  • 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.
  • 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
  • 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

Trial locations and contacts

18 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Na Yun Kim contact

+82.70.7165.7316

nykim@ilyang.co.kr

Kang Hi An contact

+82.70.7165.7322

khan@ilyang.co.kr

18 sites in 4 countries

Russia6 sites, 6 recruiting

  • Territorial State Budgetary Institution

    Barnaul, 656024

    Not yet recruiting

  • Federal State Budgetary Institution of Science

    Kirov, 610027

    Recruiting

  • Federal State Budgetary Institution

    Moscow, 125167

    Not yet recruiting

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

    Moscow, 300186883

    Recruiting

  • Federal State Budgetary Institution

    Saint Petersburg, 191024

    Recruiting

  • Federal State Budgetary Institution

    Saint Petersburg, 197341

    Recruiting

Other trials in Russia

Turkey (Türkiye)6 sites, 6 recruiting

  • Ankara University Medical Faculty

    Ankara

    Recruiting

  • Gazi University Medical Faculty

    Ankara

    Recruiting

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul

    Recruiting

  • Ege University Medical Faculty

    Izmir

    Recruiting

  • Mersin University Medical Faculty

    Mersin

    Recruiting

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun

    Recruiting

Other trials in Turkey (Türkiye)

Ukraine5 sites, 5 recruiting

  • CI Cherkasy Regional Oncological Dispensary of CRC

    Cherkassy

    Recruiting

  • CTPI Chernihiv Regional Oncological Dispensary

    Chernihiv

    Recruiting

  • CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC

    Dnipro

    Recruiting

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

    Kyiv

    Recruiting

  • SI Institute of Blood Pathology and Transfusion Medicine of AMSU

    Lviv

    Recruiting

Other trials in Ukraine

South Korea1 site, 1 recruiting

  • Uijeongbu Eulji Medical Center, Eulji University

    Uijeongbu-si, Gyeonggi-do, 11749

    Dong-Wook Kim, MD

    Dong-Wook Kim

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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.

Being tested
Radotinib HCl
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radotinib HClDrug

    Also called SUPECT

    1. Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd.
    2. Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib)
    3. Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder
    4. Storage conditions: Store in an airtight light proof container at room temperature.
Study groups in NCT03459534
Study groupRoleWhat they receive
Radotinib HClExperimentalEnrolled subjects will continue to administer Radotinib 400mg twice daily (800mg/day) orally every 12 hours at regular dosing hours for 12 months. Dose modification is allowed if the subject cannot comply with the protocol-defined dosing schedule due to hematologic or non-hematologic toxicities and toxicities resolve within 28 days (within 42 days for hematologic toxicities). For radotinib, maximum 2 dose reductions will be allowed by stage to 600mg and to 400mg.
Receives: Drug: Radotinib HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Cytogenetic Response (MCyR)

    MCyR is defined as 0~35% CCyR+PCyR based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.

    Measured: at month 6

Secondary outcomes (4)

  1. Cytogenetic Response (CCyR)

    CCyR is defined as complete loss of Ph chromosome based on ≥20 metaphase myelocytes. Chromosome test results from <20 metaphase myelocytes will be excluded from the analysis.

    Measured: at month 12/24, by month 24

  2. Major molecular response

    MMR is defined as a ≥3-log reduction in BCR-ABL1 transcript level from the standardized reference or BCR-ABL1/ABL % of ≤0.1% according to the international reference when the level of BCR-ABL1 gene was measured by RQ-PCR, a standardized quantitative genetic method.

    Measured: at month 12/24, by month 24

  3. Overall Survival(OS)

    OS is defined as the duration from the first day of Radotinib administration to the day of death for certain causes.

    Measured: by month 24

  4. Progression Free Survival (PFS)

    PFS is defined as the duration from the first day of Radotinib administration to the earliest day of disease progression or death for certain causes.

    Measured: by month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start25 Jun 2018
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
173 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459534
Sponsor's protocol ID
RT51KRI03
Other IDs
2018-003810-42, 2018
Status last verified
Sep 2026
First submitted
12 Feb 2018
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radotinib HCl in people with Chronic Myeloid Leukemia, Chronic Phase and CML, Chronic Phase, run by Il-Yang Pharm. Co., Ltd. at 18 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Russia, Turkey (Türkiye), Ukraine, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Na Yun Kim (+82.70.7165.7316, nykim@ilyang.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Cytogenetic Response (MCyR) (time frame: at month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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