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OncoMatch/Clinical Trials/NCT05586074

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

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

Phase 3RecruitingSunshine Lake Pharma Co., Ltd.NCT05586074Data as of Jun 2026Location: China

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

Treatments studied

Targeted therapy

Clifutinib

Chemotherapy

AzacitidineDecitabine

Other

LoDACAra-C±IDAFLAG-IDA

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.

Frequently asked questions

Is NCT05586074 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior FLT3 inhibitor, AML therapy disqualifies patients from enrollment.

Does this trial require FLT3?

Yes, FLT3 mutation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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