drugset / Trial / NCT04933526
The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Flumatinib | Small molecule | 600 mg | Oral |
| Comparator | dasatinib anhydrous | Small molecule | 100 mg | Oral |