RERISE China = Radotinib versus Imatinib [China]

Type of study

First line trial

Current status

No longer recruiting

Study title

Randomized Evaluation of Radotinib Versus Imatinib for Efficacy (RERISE China)

Scientific 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 (RERISE China) (ClinicalTrials.gov no. NCT03722420)

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.

What will happen during the study

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 sponsor

Il-Yang Pharm. Co., Ltd.

Scientific lead / contact

Jeong Hye Kim, Il-Yang Pharm. Co., Ltd.
Bo Hwangbo, Il-Yang Pharm. Co., Ltd.

Principal investigator

Jiang Qian
Peking University People’s Hospital

Study centers / principal investigators

China

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