Health TrialsbyHealthPanel

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

ConditionLeukemia, Acute Myeloid (AML)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Lake Pharma Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 18 years of age at the time of obtaining informed consent.

Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification;

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

Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab

Disqualifiers

Subject has received prior treatment with other FLT3 inhibitors

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

Subject has an active uncontrolled infection

Subject is known to have human immunodeficiency virus infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clifutinib

    Drug

    tablet, oral

  • LoDAC

    Drug

    subcutaneous (SC) or intravenous (IV) injection

  • Azacitidine

    Drug

    SC or IV

  • Decitabine

    Drug

    IV

  • Ara-C±IDA

    Drug

    SC and IV

  • FLAG-IDA

    Drug

    SC and IV

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: ClifutinibExperimental treatment 1 intervention
Group B: Salvage ChemotherapyActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

OS

Overall survival was defined as the time from the date of randomization until the date of death from any cause

Time frame
From the date of randomization until the date of death from any cause, assessed up to 5 years
2

CR/CRh rate

The CR/CRh rate was defined as the number of subjects who achieved either CR or CRh at any of the postbaseline visits divided by the number of subjects in the analysis population

Time frame
From randomization until the data cut-off date of April 2025, all subjects included in the primary analysis of CR/CRh rate were followed up at least 4 months

Secondary outcomes

1

EFS

EFS was defined as the time from the date of randomization until the date of documented relapse, treatment failure, new anti-leukemia therapy or death from any cause

Time frame
From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months
2

CR rate

The CR rate was defined as the number of subjects who achieved the best response of CR divided by the number of subjects in the analysis population

Time frame
From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CR rate were followed up at least 4 months
3

CRc Rate

CRc rate was defined as the number of subjects who achieved the best response of CRc (CR, CRh or CRi divided by the number of subjects in the analysis population

Time frame
From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CRc rate were followed up at least 4 months
4

Adverse Events

Number of Participants With Adverse Events

Time frame
From ICF signature date up to 30 days after the last dose of study drug, median treatment duration for Clifutinib was 140 days versus salvage chemotherapy 140 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Lake Pharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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