Phase II Study of Gilteritinib Plus Venetoclax and Azacitidine Followed by High-Dose Cytarabine Consolidation in Adults with Newly Diagnosed FLT3-ITD Positive Intermediate-Risk AML

What this Trial Is About

Researchers are evaluating a new treatment approach for fit patients aged 18 to 60 with newly diagnosed intermediate-risk acute myeloid leukemia AML that has specific FLT3-ITD mutations. The study aims to assess whether monitoring deep molecular remission can guide chemotherapy effectively and potentially allow patients to avoid allogeneic hematopoietic stem cell transplantation. The trial focuses on remission rates after initial induction therapy and survival and safety following high-dose cytarabine consolidation. The treatment involves three phases induction therapy with gilteritinib combined with venetoclax and azacitidine GVA regimen for two cycles consolidation therapy with high-dose cytarabine plus gilteritinib for three cycles if deep molecular remission is achieved and maintenance therapy with gilteritinib alone for up to three months. Molecular remission is monitored using the sensitive DeepScan assay to guide therapy decisions and treatment continuation. Participants will undergo regular assessments including molecular testing to measure remission status, with follow-up monitoring over two years to evaluate survival and relapse rates. The primary outcome is the complete remission rate after two induction cycles. Secondary outcomes include molecular remission rates, overall survival, leukemia-free survival, and relapse incidence. Safety and treatment effects will be closely observed throughout the study period.

Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML