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.
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
600 mg of Flumatinib orally daily for 24 months
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
RECRUITINGProportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Time frame: 12 months
Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MMR at 3, 6, 9 months.
Time frame: 3, 6, 9 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.
Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.
Time frame: 24 months
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