NCT05586074RecruitingPhase 3
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 324 (estimated)
- First submitted
- 14 Oct 2022
- Start date
- 3 Mar 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05586074
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 324
- From 3 Mar 2023 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the First Affiliated Hospital,College of Medicine,Zhejiang University Coordinator of this site? Confirm its status | Hanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.