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Leukemia, Acute Myeloid (AML)Phase 3NCT05586074

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

A Phase 3 study testing Clifutinib, LoDAC and Azacitidine in people with Leukemia, Acute Myeloid (AML), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Acute Myeloid (AML)
What is being tested?
Clifutinib, LoDAC and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
1 siteChina
Study dates
3 Mar 2023to 30 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion

Who cannot join

  • 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
  • Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yingzhi Jiang, MSc contact

86 13692244182

jiangyingzhi@hec.cn

China1 site, 1 recruiting

  • the First Affiliated Hospital,College of Medicine,Zhejiang University

    Hanzhou

    Jie Jin, Doctor, 0571-87236685, jiej0503@163.com

    Recruiting

Other trials in China

About this study

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

Read the detailed description

Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive Clifutinib or salvage chemotherapy. Subjects will enter the screening period up to 28 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (LoDAC), azacitidine, decitabine, Ara-C±IDA or FLAG±IDA. The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles.

After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Being tested
Clifutinib, LoDAC, Azacitidine, Decitabine, Ara-C±IDA
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClifutinibDrug

    Also called HEC73543

    tablet, oral

  • LoDACDrug

    Also called Low Dose Cytarabine

    subcutaneous (SC) or intravenous (IV) injection

  • AzacitidineDrug

    SC or IV

  • DecitabineDrug

    IV

  • Ara-C±IDADrug

    Also called Cytarabine, Idarubicin

    SC and IV

  • FLAG-IDADrug

    Also called Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin

    SC and IV

Study groups in NCT05586074
Study groupRoleWhat they receive
ClifutinibExperimentalSubjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria.
Receives: Drug: Clifutinib
Salvage ChemotherapyActive comparatorSubjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10~14 days. Subjects on azacitidine received 75 mg/m^2 daily by SC for 7 days. Subjects on decitabine received 20 mg/m^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1~3 g/m^2 daily by IV for 3 days and idarubicin 10 mg/m^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 1~2 g/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+/-2 days.
Receives: Drug: LoDAC; Drug: Azacitidine; Drug: Decitabine; Drug: Ara-C±IDA; Drug: FLAG-IDA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

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

    Measured: 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

    Measured: 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 (4)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start3 Mar 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586074
Sponsor's protocol ID
HEC73543-AML-301
Status last verified
Apr 2026
First submitted
14 Oct 2022
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clifutinib, LoDAC and Azacitidine in people with Leukemia, Acute Myeloid (AML), run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yingzhi Jiang, MSc (86 13692244182, jiangyingzhi@hec.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: From the date of randomization until the date of death from any cause, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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