NCT04677439

Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (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 flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

Detailed description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

Conditions

• Flumatinib
• Chronic Myeloid Leukemia, Chronic Phase
• Imatinib

Interventions

Type	Name	Description
DRUG	Flumatinib	600 mg of Flumatinib orally daily for 24 months

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-05-30
• Completion: 2023-12-30
• First posted: 2020-12-21
• Last updated: 2022-03-16

Locations

1 site across 1 country: China