The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Name: Flumatinib
Description: Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Measure: Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test. Time: 12 monthsDescription: Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Measure: Proportion of patients with MR 4.0 at 3, 6, 9, 12 months. Time: 3, 6, 9, 12 months.Description: Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
Measure: Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. Time: 3, 6, 9, 12 months.Description: Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.
Measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib. Time: 24 monthsAllocation: N/A
Single Group Assignment
There is one SNP
Exclusion Criteria: - Previously documented T315I mutation. --- T315I ---