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Chronic Phase Ph+ Chronic Myeloid LeukemiaNCT06665412

Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML

An observational study of Chronic Phase Ph+ Chronic Myeloid Leukemia, run by Il-Yang Pharm. Co., Ltd. at 2 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this observational study is to learn about the efficacy and safety profile when Radotinib dose redution is performed in Ph+ CML subjects. The main efficacy is checked by MMR rate by 12 months from IP treatment. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Radotinib Hydrochloride
How many people
169 participants
Where
2 sitesSouth Korea
Study dates
24 Oct 2024to 31 Dec 2027
Phase
Observational
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Newly diagnosed, CP-CML patients

Who may be able to join

  • Male or female patients aged 19 years old or older
  • Patients with confirmed diagnosis of chronic phase CML within last 8weeks(throung chromosome testing or bone marrow testing)
  • Chronic phase CML is defined as follows:
  • 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%
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  • Platelets count ≥ 50 × 109/L (≥ 50,000/mm3) (But, transient prior therapy related thrombocytopenia [<50 × 109/L (< 50,000/mm3)] is acceptable)
  • No extramedullary involvement other than enlargements of liver and spleen
  • Patients with positive Philadelphia chromosome and confirmed expression of BCR:ABL1 transcript
  • ECOG scale 0, 1 or 2
  • 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.
  • Patients providing written informed consent form before the study related screening procedures.

Who cannot join

  • Patients with Philadelphia chromosome negative
  • Patients who used Radotinib for 8 days or longer before study entry
  • Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells
  • Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product.
  • Patients with impaired cardiac function as defined below:
  • Patients who cannot have QT intervals measured according to ECG
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  • Complete left bundle branch block
  • Patients with cardiac pacemakers
  • Patients with congenital long QT syndrome or the family history of known long QT syndrome
  • The mean QTcF >450msec ECG tests at baseline
  • Clinically significant resting bradycardia (< 50 bpm) History of, or presence of symptomatic ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia (< 50 bpm)
  • Medical history of clinically confirmed myocardial or infarctionof unstable angina (within last 12 months)
  • Other clinically significant cardiac disease (e.g. congestive heart failure, or uncontrolled hypertension)
  • Cytologically confirmed CNS involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)
  • Severe or uncontrolled chronic medical condition (e.g., uncontrolled diabetes, active or uncontrolled infection)
  • Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia
  • Patients who previously received radiotherapy to at least 25% of the bone marrow
  • Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery
  • Patients who diagosed with another clinically significant malignant tumor wihin 5years before study etnry, excluding basal cell carcinoma
  • Patients who are currently receiving treatment with a strong CYP3A4 inhibitor (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) or CYP3A4 inducer (e.g., dexamthasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St. John's Wort). Treatment cannot be safely discontinued or switched to a different medication prior to initiation of study treatment
  • Patients who are currently receiving treatment with a medication that has the potential to prolong the QT interval. Treatment cannot be safely discontinued or switched to a different medication prior to initiation of study treatment
  • Impairment of GI function or GI disease that may significantly alter absorption of study drugs (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, GI bypass surgery).
  • History of acute or chronic pancreatitis within last one year
  • Acute or chronic liver or pancreas disease or severe renal disease
  • Patients with HbsAg, HCV Ab positive
  • following subjects can be enrolled.
  • Inactive hepatitis B surface antigen (HBsAg) carriers(site specific local lab normal range lower limit assessed by investigator)
  • undergoding HCV Ab or HCV RNA testing judged by investigator to be eligible for enroll
  • History of HIV Ab positive or confirmed HIV Ab positvie.
  • Pregnant or the women with breast-feeding 2

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Hallym University Sacred Heart Hosptial

    Anyang-si, Gyeonnggi-do, 14068

  • Keimyung University Daegu Dongsan Hospital

    Daegu, 42601

Other trials in South Korea

About this study

Official title: A Single-arm, Open-label, Multicenter, Investigator-led Observational Study to Evaluate the Efficacy and Safety of Dose Reduction of Radotinib as a First-line Treatment in Patients With Newly Diagnosed Chronic Phase Ph+ Chronic Myeloid Leukemia.

The goal of this observational study is to learn about the efficacy and safety profile when Radotinib dose redution is performed in Ph+ CML subjects.

The main efficacy is checked by MMR rate by 12 months from IP treatment.

Being tested
Radotinib Hydrochloride

What participants receive

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

  • Radotinib HydrochlorideDrug

    200mg BID, every day up to 12months

What is being measured

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

  1. To evaluate MMR rate up to 12months following the treatment of Radotinib

    Measured: up to 12months

Timeline

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

  1. First posted30 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06665412
Sponsor's protocol ID
RT51KR-IIT01
Status last verified
Sep 2026
First submitted
28 Oct 2024
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?

An observational study of Chronic Phase Ph+ Chronic Myeloid Leukemia, run by Il-Yang Pharm. Co., Ltd. at 2 sites in South Korea.

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 19 inclusion and 31 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: under way, not looking for participants, 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 2 sites in 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate MMR rate up to 12months following the treatment of Radotinib (time frame: up to 12months). 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 NCT06665412.

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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