LoDAC: subcutaneous (SC) or intravenous (IV) injection
Azacitidine: SC or IV
Decitabine: IV
Ara-C±IDA: SC and IV
FLAG-IDA: SC and IV
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
OS — From the date of randomization until the date of death from any cause, assessed up to 5 years Overall survival was defined as the time from the date of randomization until the date of death from any cause
CR/CRh rate — 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 The CR/CRh rate was defined as the number of subjects who achieved either CR or CRh at any of the postbaseline visits divided by the number of subjects in the analysis population
Trial sites (1)
Facility
City
Region
Status
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou
China
Recruiting
More Sunshine Lake Pharma Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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