The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Flumatinib 600mg QD orally form 1 to 12 months
Dasatinib 100mg QD orally form 1 to 12 months
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
RECRUITINGChange of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.
Time frame: 3 months
Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.
Time frame: 12 months
Time to optimal imatinib-related adverse event improvement.
Time frame: 12 months
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