NCT04933526

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

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: an Randomized Controlled Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myeloid Leukemia in Chronic Phase

Interventions

Type	Name	Description
DRUG	Flumatinib	Flumatinib 600mg QD orally form 1 to 12 months
DRUG	Dasatinib	Dasatinib 100mg QD orally form 1 to 12 months

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-04-30
• Completion: 2023-06-30
• First posted: 2021-06-21
• Last updated: 2022-07-27

Locations

1 site across 1 country: China