RT51KR-IIT01 = Efficacy and Safety of Dose Reduction of Radotinib as a First Line Treament in Ph+ CML [Republic of Korea]
Study title
Efficacy and Safety of Dose Reduction of Radotinib as a First Line Treament in Ph+ CML
Scientific 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.
Type of study
First-line trial
Current status
Recruiting
Other trial ID
ClinicalTrials.gov no. NCT06665412
What is the purpose of the study
The goal of this observational study is to learn about the efficacy and safety of radotinib when the dose is reduced in Ph+ CML subjects.
What will happen during the study
Study participants will receive radotinib 200 mg twice daily for 12 months.
Key inclusion criteria
This study includes male or female patients who:
- are 19 years or older
- have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) within 8 weeks of study entry
- have positive Philadelphia chromosome (Ph+) and confirmed expression of BCR:ABL1 transcript
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate organ function.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have negative Philadelphia chromosome
- used radotinib for 8 days or longer before study entry
- had been treated with other targeted anti-cancer therapy, except for hydrea or agrylin
- have impaired heart function
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Il-Yang Pharm. Co., Ltd.
Scientific lead / contact
Na Yun Kim,Il-Yang Pharm. Co., Ltd.
Principal investigator
Study centers / principal investigators
Korea, Republic of
Daegu, 42601
Keimyung University Daegu Dongsan Hospital
Anyang-si, Gyeonnggi-do, 14068
Hallym University Sacred Heart Hospital