Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- China who are 18 years of age or older.
- Eastern cooperative oncology group (ECOG) score 0, 1, or 2.
- Patients with confirmed diagnosis of CML-CP within last 6 months.
- Patients with cytogenetically confirmed Ph+ CML in chronic phase
- Patients with typical BCR-ABL1 transcript type such as b2a2 and b3a2.
- Patients with adequate organ function.
- Women of childbearing potential should have negative serum or urine pregnancy test within 14 days before study entry.
- Patients providing written informed consent before initiation of any study-related activities.
EXCLUSION CRITERIA
Exclusion Criteria:
- Patients with Philadelphia chromosome negative but BCR-ABL1 positive CML.
- Patients who had been treated with interferon or other targeted anti-cancer therapy which inhibits the growth of leukemic cells
- Concurrently clinically significant primary malignancy
- Patients who previously received radiotherapy
- Patients with impaired cardiac function.
- uncontrolled chronic medical condition
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chronic Myeloid Leukemia, Chronic Phase
Age (in years)
18+
Phase
Phase 3
Participants needed
238
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional
Sponsor
Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov identifier
NCT03722420
Study number
RT51CN03
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