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OncoMatch/Clinical Trials/NCT05586074

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

Is NCT05586074 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for leukemia, acute myeloid (aml).

Phase 3RecruitingSunshine Lake Pharma Co., Ltd.NCT05586074Data as of May 2026

Treatment: Clifutinib · LoDAC · Azacitidine · Decitabine · Ara-C±IDA · FLAG-IDAA 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: FLT3 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: AML therapy — first-line

Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant )

Cannot have received: FLT3 inhibitor

Subject has received prior treatment with other FLT3 inhibitors

Cannot have received: AML therapy

Subject has AML that has relapsed after or is refractory to more than 1 line of therapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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