Can a lower dose of a leukemia drug keep the disease in check?

NCT ID NCT06665412

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether reducing the dose of the cancer drug radotinib can still control chronic myeloid leukemia in its early phase while possibly easing side effects. Adults newly diagnosed with this blood cancer take a lower dose twice daily for up to a year. Researchers measure how many patients achieve a major molecular response, a sign the leukemia is well controlled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radotinib hydrochloride, a targeted cancer drug taken as a pill twice daily
What this could lead to
If lowering the dose works, patients with chronic myeloid leukemia might achieve remission with fewer side effects, improving quality of life.
What could go wrong
This is an early, single-arm study without a comparison group, so results may not prove the lower dose is as effective as the standard one. Some patients might still experience side effects or inadequate response.
Why investors are watching

Il-Yang Pharm is running an observational study of 169 patients with newly diagnosed chronic phase chronic myeloid leukemia to see if lowering the dose of its drug radotinib still controls the disease. The main measure is the rate of major molecular response at 12 months. For a small company, this readout matters because radotinib is a core product, and evidence that a lower dose works could shape how doctors prescribe it and how the drug competes.

If it works: A positive result could support radotinib's use as a first-line treatment with a better safety profile, which may strengthen its position in the market and encourage broader adoption. It could also give the company data to discuss with regulators or partners.

If it fails: If the lower dose fails to control the disease or shows safety problems, doctors may lose confidence in radotinib, and the company could face slower sales or added costs. Observational studies often produce unclear results, and the trial could also face delays or enrollment issues.

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.

Participants

169 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 2027

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.

Who is studied

Newly diagnosed, CP-CML patients

Ages

19 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 19 years old or older 2. 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% * 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 3. Patients with positive Philadelphia chromosome and confirmed expression of BCR:ABL1 transcript 4. ECOG scale 0, 1 or 2 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 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. 8. Patients providing written informed consent form before the study related screening procedures. Exclusion Criteria: 1. Patients with Philadelphia chromosome negative 2. Patients who used Radotinib for 8 days or longer before study entry 3. Patients who had been treated with other targeted anti-cancer therapy, except for Hydrea or Agrylin, which inhibits the growth of leukemic cells 4. Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product. 5. Patients with impaired cardiac function as defined below: * 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 * 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) 6. Cytologically confirmed CNS involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment) 7. Severe or uncontrolled chronic medical condition (e.g., uncontrolled diabetes, active or uncontrolled infection) 8. Other significant congenital or acquired bleeding disorders that are not related to underlying leukemia 9. Patients who previously received radiotherapy to at least 25% of the bone marrow 10. Patients who had a major surgery within 4 weeks prior to study entry or has not recovered from side effects of such surgery 11. Patients who diagosed with another clinically significant malignant tumor wihin 5years before study etnry, excluding basal cell carcinoma 12. 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 13. 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 14. 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). 15. History of acute or chronic pancreatitis within last one year 16. Acute or chronic liver or pancreas disease or severe renal disease 17. 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 18. History of HIV Ab positive or confirmed HIV Ab positvie. 19. Pregnant or the women with breast-feeding 2

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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.

Contacts and locations

Locations

  • Hallym University Sacred Heart Hosptial

    Anyang-si, Gyeonnggi-do, 14068, South Korea

  • Keimyung University Daegu Dongsan Hospital

    Daegu, 42601, South Korea