Clinical Research Directory
Browse clinical research sites, groups, and studies.
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
Sponsor: Il-Yang Pharm. Co., Ltd.
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).
Official title: A Phase III, Multi-center, Open-Label, Randomized Study of the Efficacy of Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Chinese Patients in Chronic Phase
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2018-12-28
Completion Date
2025-06-30
Last Updated
2024-10-28
Healthy Volunteers
No
Conditions
Interventions
Radotinib
Patients randomized to the radotinib arms will receive 300 mg of radotinib BID (1 in the morning and 1 in the evening, at approximately 12-hour intervals).
Imatinib
Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
Locations (1)
Peking University People's Hospital(北京大学人民医院)
Beijing, China