It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Name: flumatinibDescription: Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.Type: Drug
flumatinib 400mg qd flumatinib 600 mg qd
Name: imatinibDescription: Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.Type: Drug
Description: Obtain major molecular response (MMR) rate at 6 months in newly diagnosed Ph+ CML patients through comparison of the efficacy results of flumatinib with that of imtinib.Measure: To compare the rate of MMR at 6 months Time: 6 months
There is one SNP
Exclusion Criteria: 1. Previously documented T315I mutations. --- T315I ---