RecruitingPhase 3NCT05586074

HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial


Sponsor

Sunshine Lake Pharma Co., Ltd.

Enrollment

324 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized,multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new targeted drug called HEC73543 against standard salvage chemotherapy in people with relapsed or refractory AML (acute myeloid leukemia) that has a specific mutation called FLT3-ITD. FLT3-ITD is a mutation that makes leukemia grow faster and is linked to poorer outcomes. **You may be eligible if...** - You are 18 or older - You have AML (primary or secondary to MDS) that has relapsed or not responded to first-line treatment - Your AML cells test positive for the FLT3-ITD mutation - You are in good enough health to receive salvage chemotherapy **You may NOT be eligible if...** - You have previously been treated with another FLT3 inhibitor drug - Your AML relapsed after or did not respond to more than one prior treatment line - You have certain serious medical conditions that make the treatment unsafe 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

tablet, oral

DRUGLoDAC

subcutaneous (SC) or intravenous (IV) injection

DRUGAzacitidine

SC or IV

DRUGDecitabine

IV

DRUGAra-C±IDA

SC and IV

DRUGFLAG-IDA

SC and IV


Locations(1)

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, China

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NCT05586074


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