RecruitingNot Applicable

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

South Korea168 participantsStarted 2024-10-24

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. 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:
. 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.

Exclusion criteria

. Patients with Philadelphia chromosome negative
. Patients who used Radotinib for 8 days or longer before study entry

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 12months

Trial details

NCT IDNCT06665412

SponsorIl-Yang Pharm. Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

Na Yun Kim

82-70-7165-7316 nykim@ilyang.co.kr

View on ClinicalTrials.gov More Chronic Phase Ph+ Chronic Myeloid Leukemia trials