Trials / Recruiting
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.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 168 (estimated)
- Sponsor
- Il-Yang Pharm. Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radotinib Hydrochloride | 200mg BID, every day up to 12months |
Timeline
- Start date
- 2024-10-24
- Primary completion
- 2026-09-30
- Completion
- 2026-12-31
- First posted
- 2024-10-30
- Last updated
- 2024-10-30
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06665412. Inclusion in this directory is not an endorsement.