Tests clifutinib against chemotherapy in adults with returned FLT3-mutated acute myeloid leukemia
Compares clifutinib with chemotherapy in adults whose leukemia returned or did not respond.
Plain-language title generated from the registry record
Registry title: HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
Key facts
- Where
- Hanzhou, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) came back or did not respond to first treatment and who have a FLT3 mutation. It compares Clifutinib with salvage chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Primary AML or AML after myelodysplastic syndrome (MDS), that came back after or did not respond to first-line therapy (with or without a stem cell transplant). Daily activity level (ECOG) of 0-2.
- Earlier treatment
- Must have had first-line AML treatment that failed. Cannot have had other FLT3 inhibitors, or more than 1 line of therapy for relapsed or refractory AML.
- Biomarker or test result
- FLT3 mutation in bone marrow or blood, confirmed by the central lab.
Main reasons for not taking part
- Earlier treatment with other FLT3 inhibitors
- AML that relapsed after or did not respond to more than 1 line of therapy
- Active infection that is not under control
- Known HIV infection
- Any condition the investigator thinks makes joining unsuitable
Read by machine on 12 November 2026.
Where in China
- the First Affiliated Hospital,College of Medicine,Zhejiang UniversityHanzhou, ChinaContact: Jie Jin, DoctorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunshine Lake Pharma Co., Ltd.
- Trial code
- NCT05586074
- Record updated
- 28 April 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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.