HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (NCT05586074) | Clinical Trial Compass
RecruitingPhase 3
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
China324 participantsStarted 2023-03-03
Plain-language 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 CR/CRh rate in these subjects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing HEC73543 directly against salvage chemotherapy — what does my doctor think the current evidence suggests about how HEC73543 might perform compared to the chemotherapy options I'd otherwise receive for my relapsed or refractory FLT3-ITD AML?
2Since the trial is measuring overall survival and complete remission rates as its main goals, can my doctor explain what 'complete remission with partial hematologic recovery' (CRh) means in practice, and why achieving that response matters for my long-term outlook?
3My AML has a FLT3-ITD mutation specifically — how important is that mutation status to whether this trial might even be relevant to discuss, and has my doctor confirmed my test results clearly show FLT3-ITD?
4Because this is a trial in relapsed or refractory AML, is there any standard treatment my doctor would recommend trying first before considering enrollment here, or does my specific situation make this trial worth exploring right now?
5What are the known or expected side effects of HEC73543 so far, and how do they compare to the salvage chemotherapy I would receive outside the trial — especially given that Phase 3 means some earlier safety data exists but it's still being studied in a larger population?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
OS
Timeframe: From the date of randomization until the date of death from any cause, assessed up to 5 years
2
CR/CRh rate
Timeframe: 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