HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clifutinib, LoDAC, Azacitidine, Decitabine.
- Who it may be relevant to
- Registry conditions: Leukemia, Acute Myeloid (AML). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
Overview
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.
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.
Interventions
- Drug Clifutinib
tablet, oral - Drug LoDAC
subcutaneous (SC) or intravenous (IV) injection - Drug Azacitidine
SC or IV - Drug Decitabine
IV - Drug Ara-C±IDA
SC and IV - Drug FLAG-IDA
SC and IV
Primary outcome measures
- OS [Time frame: 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]
Secondary outcome measures (4)
- EFS [Time frame: 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]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital,College of Medicine,Zhejiang University — Hanzhou
Identifiers
NCT: NCT05586074 · HEC73543-AML-301