Phase 3 Study Comparing Clifutinib to Salvage Chemotherapy in Adults with Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

What this Trial Is About

This trial investigates the clinical benefits of Clifutinib compared to salvage chemotherapy in Chinese patients aged 18 and older with relapsed or refractory FLT3-mutated acute myeloid leukemia AML. The study aims to evaluate overall survival and the effectiveness of Clifutinib based on complete remission rates. It is an open-label, randomized Phase III study involving multiple centers. Participants are randomly assigned in a 21 ratio to receive either Clifutinib or one of several salvage chemotherapy regimens, which are pre-selected before randomization. Clifutinib is given orally once daily in continuous 28-day cycles, while chemotherapy options include low-dose cytarabine, azacitidine, decitabine, Ara-CIDA, or FLAG-IDA, each administered in 28-day cycles with specific dosing schedules. Treatment continues until criteria for discontinuation are met. During the study, participants undergo a screening period up to 28 days prior to treatment start. After treatment ends, there is an end-of-treatment visit within 7 days and a 30-day safety follow-up. Long-term follow-up visits occur every 90 days. Researchers assess overall survival from randomization until death from any cause over up to 5 years and measure remission rates within at least 4 months of follow-up. Safety monitoring continues throughout the study period.

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