RecruitingPhase 1Phase 2NCT05133882

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia


Sponsor

Sunshine Lake Pharma Co., Ltd.

Enrollment

133 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called clifutinib besylate combined with standard chemotherapy for people newly diagnosed with acute myeloid leukemia (AML), a fast-growing blood cancer. **You may be eligible if...** - You are 18–65 years old (Cohort 1) OR 60 or older and cannot tolerate intensive chemotherapy (Cohort 2) - You have been newly diagnosed with AML (primary or secondary to MDS) with no prior treatment - For the extended phase: your AML must have a specific genetic change called FLT3-ITD mutation - You meet the health and performance status criteria **You may NOT be eligible if...** - You have already received treatment for AML - You do not have the required genetic mutation (for extended phase) - Your overall health does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClifutinib Besylate

The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs


Locations(1)

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, Zhejiang, China

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NCT05133882


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