drugset / Trial / NCT04933526

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

NCT04933526

Phase 4 Unknown 118 enrolled Shenzhen Second People's Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-07-01
Primary completion
2023-04-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Flumatinib Small molecule 600 mg Oral
Comparator dasatinib anhydrous Small molecule 100 mg Oral