Comparing Venetoclax Plus Azacitidine With Standard Chemotherapy for Consolidation in Adults With Intermediate-Risk AML

What this Trial Is About

Researchers are evaluating the effectiveness and safety of venetoclax-based consolidation therapy compared to standard chemotherapy in adults newly diagnosed with intermediate-risk acute myeloid leukemia AML. This study focuses on patients who have achieved complete remission or remission with incomplete blood recovery after initial treatment with venetoclax and azacitidine and are preparing for allogeneic stem cell transplantation. The purpose is to determine if venetoclax plus azacitidine provides similar benefits to conventional chemotherapy with potentially fewer side effects. Participants will be randomly assigned to receive either 1 to 2 cycles of venetoclax 400 mg orally daily for 28 days combined with azacitidine 75 mgm given under the skin or intravenously for 7 days or 1 to 2 cycles of intermediate or high-dose cytarabine chemotherapy, possibly combined with anthracycline drugs, delivered intravenously. After completing consolidation therapy, patients will proceed to stem cell transplantation as planned. During the study, participants will be monitored for leukemia-free survival over two years, with evaluations including relapse rates, overall survival, and safety assessments of adverse events during and up to 30 days after treatment. Additional measures include minimal residual disease status before transplantation and mortality unrelated to relapse. The study is designed to gather detailed safety and effectiveness data to guide consolidation therapy decisions in this patient group.

VA Consolidation in Intermediate-Risk AML