# A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

> **NCT03459534** · PHASE3 · RECRUITING · sponsor: **Il-Yang Pharm. Co., Ltd.** · enrollment: 173 (estimated)

## Conditions studied

- Chronic Myeloid Leukemia, Chronic Phase
- CML, Chronic Phase
- CML, Refractory
- CML - Philadelphia Chromosome

## Interventions

- **DRUG:** Radotinib HCl

## Key facts

- **NCT ID:** NCT03459534
- **Lead sponsor:** Il-Yang Pharm. Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2018-06-25
- **Primary completion:** 2026-06-30
- **Final completion:** 2027-12-31
- **Target enrollment:** 173 (ESTIMATED)
- **Last updated:** 2024-10-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03459534

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03459534, "A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs". Retrieved via AI Analytics 2026-05-31 from https://api.ai-analytics.org/clinical/NCT03459534. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
