Leukemia, Acute Myeloid (AML)
Conditions
Brief 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.
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
DRUGClifutinib
tablet, oral
DRUGLoDAC
subcutaneous (SC) or intravenous (IV) injection
DRUGAzacitidine
SC or IV
DRUGDecitabine
IV
DRUGAra-C±IDA
SC and IV
DRUGFLAG-IDA
SC and IV
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFS | From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months | 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 |
| CR rate | 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 | 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 |
| CRc Rate | 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 | 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 |
| Adverse Events | 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 | Number of Participants With Adverse Events |
Countries
China
Contacts
CONTACTYingzhi Jiang, MSc
PRINCIPAL_INVESTIGATORJie Jin, MD, PhD
First Affiliated Hospital of Zhejiang University
Outcome results
None listed