Study on Venetoclax and Azacitidine Combined With HAAG for Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment using venetoclax, azacitidine, and the HAAG regimen for patients newly diagnosed with intermediate and high-risk acute myeloid leukemia (AML). This single-center, single-arm, prospective clinical study focuses on induction treatment for these AML patients, aiming to assess how well this combined approach works and its safety profile. Participants will receive venetoclax orally with a dose escalation schedule from day 1 to day 10, azacitidine as a daily subcutaneous injection for seven days, and the HAAG regimen consisting of homoharringtonine, aclarubicin, cytarabine, and granulocyte colony-stimulating factor administered through intravenous or subcutaneous injections over specific days. The treatment is planned during the induction phase, and the study is designed to closely monitor patients receiving this combined therapy. During the study, participants will undergo evaluations including response rates measured between days 28 and 35 of induction, along with monitoring for adverse events over two years. The research team will also track relapse-free survival and overall survival for up to three years. Patients will be assessed through clinical visits and laboratory tests to monitor treatment effects and safety throughout the study period, which spans from enrollment until the end date in December 2026.

Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients