RERISE China = Radotinib versus Imatinib [China]

What is the purpose of the study

This study will evaluate the efficacy of radotinib compared to imatinib 300 mg twice a day compared to imatinib 400 mg in patients with Ph+ CML in chronic phase.

Patients will be randomized to receive either radotinib 300 mg twice daily by mouth or imatinib 400 mg once a day by mouth. All patients will be treated and/or followed for 12 months (48 weeks) after randomization.

Key inclusion criteria

This study includes male or female patients who:

– are at least 18 years old
– have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
– have been diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of enrolment
– have cytogenetically confirmed Philadelphia chromosome (Ph+) CML and typical BCR-ABL1 transcript such as b2a2 and b3a2
– have adequate organ function

Other criteria may apply.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

China

Peking University People’s Hospital
Beijing, 100044
Principal Investigator: Jiang Qian