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

April 27, 2026 updated by: Sunshine Lake Pharma Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hanzhou, China
        • Recruiting
        • the First Affiliated Hospital,College of Medicine,Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clifutinib
Subjects 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.
Drug: Clifutinib
tablet, oral
Other Names:
  • HEC73543
Active Comparator: Salvage Chemotherapy
Subjects 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.
Drug: LoDAC
subcutaneous (SC) or intravenous (IV) injection
Other Names:
  • Low Dose Cytarabine
Drug: Azacitidine
SC or IV
Drug: Decitabine
IV
Drug: Ara-C±IDA
SC and IV
Other Names:
  • Cytarabine, Idarubicin
Drug: FLAG-IDA
SC and IV
Other Names:
  • Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 5 years
Overall survival was defined as the time from the date of randomization until the date of death from any cause
From the date of randomization until the date of death from any cause, assessed up to 5 years
CR/CRh rate
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS
Time Frame: From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months
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
From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months
CR rate
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
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
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
CRc Rate
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
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
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
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
Number of Participants With Adverse Events
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunshine Lake Pharma Co., Ltd.

Investigators

  • Principal Investigator: Jie Jin, MD, PhD, First affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 16, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEC73543-AML-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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