Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

Summary

This is a Phase III, multi-center, open-label, parallel, 2-arm, randomized study to evaluate the efficacy and safety of radotinib 300 mg Bis In Die(BID) versus imatinib 400 mg Quaque Die(QD). This study will be conducted in Chinese patients with newly diagnosed Ph+ Chronic Myelogenous Leukemia(CML)-Chronic Phase(CP) who are previously untreated for Chronic Myelogenous Leukemia(CML).

Timeline

Start

2018-12-28

Primary completion

2023-03-03

Completion

2025-06-30

Publications

• Lee Y, Kim J, Kang M, Han J, Kim NY, Shin JS, Park MS, Jiang Q, Lee JI. Clinical pharmacokinetic characteristics and the food effect of radotinib. Invest New Drugs. 2026 Mar 27. doi: 10.1007/s10637-026-01610-6. Online ahead of print.

Drugs

Indications