RERISE China = Radotinib versus Imatinib [China]

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

First line trial

Current status

Recruiting

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

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