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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
tablet, oral
subcutaneous (SC) or intravenous (IV) injection
SC or IV
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China
RECRUITINGOS
Overall survival was defined as the time from the date of randomization until the date of death from any cause
Time frame: From the date of randomization until the date of death from any cause, assessed up to 5 years
CR/CRh rate
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
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
EFS
EFS was defined as the time from the date of randomization until the date of documented relapse, treatment failure, new anti-leukemia therapy or death from any cause
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
The CR rate was defined as the number of subjects who achieved the best response of CR divided by the number of subjects in the analysis population
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
CRc rate was defined as the number of subjects who achieved the best response of CRc (CR, CRh or CRi divided by the number of subjects in the analysis population
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
Number of Participants With Adverse Events
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IV
SC and IV
SC and IV
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