A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia

OS

An open-label design is adopted in this study. All patients will first undergo pre-screening
 to determine the mutation status of IDH, and all patients will be assigned to the registry
 study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results.
 Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is
 divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort
 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed
 independently and will be analyzed separately for statistical hypothesis testing. Patients in
 both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web
 Response System (IWRS) into the test or control group, patients in the test group will
 receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD
 [starting from Cycle 2 (C2)]. Patients in the control group will receive salvage chemotherapy
 (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG
 ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC)