NCT05353205

A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

A Double-blind , Randomized, Multicenter, Phase 4 Study to Evaluate Efficacy and Safety of Oral Flumatinib 400mg Versus 600mg in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

It's a double-blind , randomized ,multi-center study. The purpose of this study is to explore the efficacy and safety of flumatinib 400mg once daily (QD) versus 600mg QD as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).

Detailed description

This is a dose-optimization study of flumatinib in adult patient with newly diagnosed CML-CP. The objective of this study is to compare the efficacy and safety of flumatinib 400mg QD with that of 600mg QD. Eligible patients are randomized in a 1:1 ratio to receive either fluamtinib 400mg QD or flumatinib 600mg QD. Randomization is stratified based on Sokal risk score (\<0.8,0.8\~1.2,\>1.2). Patients will discontinue study therapy due to treatment failure, disease progression or intolerance to study medication or due to investigator's or participant's decision. The primary efficacy endpoint is the rate of early molecular response , as measured by RQ-PCR at 3 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion.

Conditions

• CML, Chronic Phase

Interventions

Type	Name	Description
DRUG	Flumatinib mesylate tablets (400mg)	Flumatinib 400mg +Placebo for flumatinib are administered orally daily. Patients are randomized to flumatinib 400mg QD.
DRUG	Flumatinib mesylate tablets (600mg)	Flumatinib 600mg is administered orally daily. Patients are randomized to flumatinib 600mg QD.

Timeline

• Start date: 2021-11-23
• Primary completion: 2022-12-30
• Completion: 2025-09-30
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: China