A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

CML, Chronic Phase Clinical Trial

Official title: Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study

Status Not yet recruiting

Clinical Trial Summary

Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Clinical Trial Description

The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical treatment of CML-CP in China. The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days) ;

Related Conditions & MeSH terms

• CML, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

• NCT number: NCT05367765
• Study type: Interventional
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Jun Ma
• Phone: 13304518000
• Email: majun0322@126.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 30, 2022
• Completion date: April 30, 2028