RecruitingNCT06665412

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

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.


Sponsor

Il-Yang Pharm. Co., Ltd.

Enrollment

168 participants

Start Date

Oct 24, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a lower dose of radotinib — a drug that blocks the abnormal protein driving chronic myeloid leukemia (CML) — can work just as well as the standard dose while causing fewer side effects in patients newly diagnosed with chronic phase CML that has the Philadelphia chromosome (a specific genetic abnormality). **You may be eligible if...** - You are 19 or older - You have been newly diagnosed with chronic phase CML within the past 8 weeks - Your diagnosis has been confirmed by chromosome or bone marrow testing - You have the Philadelphia chromosome (BCR-ABL1 gene change) confirmed - Your organ function (liver, kidneys) meets acceptable levels - You are generally healthy enough to participate (ECOG score 0-2) **You may NOT be eligible if...** - Your CML is in an accelerated or blast phase (more advanced stage) - You have already started treatment for CML - You have serious liver, kidney, or pancreatic problems - You are pregnant, breastfeeding, or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRadotinib Hydrochloride

200mg BID, every day up to 12months


Locations(2)

Hallym University Sacred Heart Hosptial

Anyang-si, Gyeonnggi-do, South Korea

Keimyung University Daegu Dongsan Hospital

Daegu, South Korea

View Full Details on ClinicalTrials.gov

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NCT06665412