Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
Men or women aged more than or equal to (≥) 18 years.
Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
Eastern Cooperative Oncology Group (ECOG) performance status: 0~2.
Signed and dated Informed Consent Form.
Patients with previously documented T315I mutation.
Received BCR-ABL TKI(s) treatment before enrollment.
Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
Parallel
Flumatinib
DrugFlumatinib 600mg orally daily
Imatinib
DrugImatinib 400mg orally daily (Reference drug instructions)
Major molecular response (MMR) rate at 12 months
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
MMR rate of high-risk population treated at the end of 12 months
* High-risk population：Sokal score\>1.2 * MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
MMR rate at 6, 24 and 36 Months
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months
Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample. CCyR is defined as 0% Ph+ metaphases in the bone marrow.
Percentage of participants with transformation-free survival (TFS)
TFS was defined as the time between the first dose and the date of transition to AP/BP or the last efficacy assessment during treatment.
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