HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
About this study
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.
- Condition
- Leukemia, Acute Myeloid (AML)
- Tested
- Clifutinib, LoDAC, Azacitidine, Decitabine, Ara-C±IDA, FLAG-IDA
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Leukemia, Acute Myeloid (AML)
- 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 5
- 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
Where
1 site, 1 recruiting
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China
Contact
-
Yingzhi Jiang, MSc
86 13692244182 jiangyingzhi@hec.cn
Potential match only. Final eligibility is determined by the study team.