HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

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.

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