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Clinical Trial Summary

This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML


Clinical Trial Description

Main purpose:To evaluate the tolerability and safety of Clifutinib Besylate combined with DA (Cytarabine + Daunorubicin) or AZA (Azacitidine) in newly-treated adult AML subjects; explore reasonable therapeutic doses through climbing tests in different dose groups. To evaluate the efficacy of Clifutinib Besylate combined with DA or AZA in newly treated adult AML subjects. Secondary purpose:To observe the pharmacokinetic (PK) characteristics of Clifutinib combined with DA or AZA in newly-treated adult AML subjects and the drug interaction between Clifutinib and AZA at the same time.Observe the correlation of different subtypes and prognostic risk with the efficacy of Clifutinib and the changes of genes before and after treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05133882
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact Jie Jin, Doctor
Phone 0571-87236685
Email jiej0503@163.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 1, 2022
Completion date October 7, 2026

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