drugset / Trial / NCT02204644

The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML

NCT02204644 ↗

Phase 3 Completed 400 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. Randomized,Open Label,Control

Timeline

Start
2014-06
Primary completion
2017-06
Completion
2017-12

Outcome

Met primary endpoint

paper The rate of major molecular response (MMR) at 6 months (primary endpoint) was significantly higher with flumatinib than with imatinib (33.7% vs. 18.3%; P = 0.0006) PMID 32928796 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Flumatinib Small molecule 600 mg —
Comparator Imatinib Small molecule 400 mg —