The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients

  • End date
    Jun 30, 2023
  • participants needed
  • sponsor
    Shenzhen Second People's Hospital
Updated on 4 October 2022


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.

Condition Chronic Myeloid Leukemia in Chronic Phase
Treatment dasatinib, Flumatinib
Clinical Study IdentifierNCT04933526
SponsorShenzhen Second People's Hospital
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Diagnosis of CML-CP with Ph+
ECOG 0, 1, or 2
Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months
Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria

Previously documented T315I mutation
Previous treatment with any other tyrosine kinase inhibitor except for imatinib
Prior accelerated phase or blast phase CML
Loss of CHR or cytogenetic response
Clear my responses

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