The purpose of this study is to determine the clinical benefit of XY0206 therapy in participants with FLT3-ITD mutated AML who are refractory to or have relapsed after prior AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study is also to investigate the efficacy of XY0206 as assessed by CR/CRh rate in these subjects。
Age≥18 years old.
Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.
Advanced relapse after first-line AML therapy is defined as: the patients achieved Complete remission without minor residual diseases/complete remission/complete remission with partial hematologic recovery/complete remission with incomplete hematologic recovery/complete remission with incomplete platelet recovery/Morphologic leukemia- free state(CRMRD-/CR/CRh/CRi/CRp/MLFS )after first-line treatment and relapsed after 12 months with hematological relapse;
Patients with relapsed / refractory AML.
Patient was diagnosed as acute promyelocytic leukemia (APL), or Philadelphia chromosome（BCR-ABL）-positive leukemia (chronic myelogenous leukemia in blast crisis).
Patients who received live vaccine (including live attenuated vaccine) within 4 weeks before randomization and/or planed to receive live vaccine after enrollment.
Presence of FLT3-tyrosine kinase domain(TKD) mutation.
Patients were prior failed adequate treatment with FLT3 inhibitors.