Actively Recruiting
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-28
324
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 218 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China
Actively Recruiting
Research Team
Y
Yingzhi Jiang, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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