Phase II Study of Venetoclax Combined With Intensive Chemotherapy for Adults Aged 14 to 60 With Different Types of Acute Myeloid Leukemia

What this Trial Is About

This research aims to evaluate the effectiveness of combining Venetoclax with intensive chemotherapy in adult patients with acute myeloid leukemia AML, a common blood cancer. The study focuses on different genetic subgroups of AML to understand which types may benefit most from this combination treatment. It is a phase II clinical trial designed to explore how Venetoclax works with chemotherapy across various molecular and cytogenetic profiles of AML. Participants will receive one course of induction therapy combining daunorubicin, cytarabine, and Venetoclax. Those who achieve complete remission will then undergo three courses of consolidation therapy with intermediate-dose cytarabine combined with Venetoclax. After consolidation, maintenance treatment consists of six courses of Venetoclax combined with azacitidine. For high-risk patients or those with positive measurable residual disease, allogeneic stem cell transplantation is recommended. During the study, participants will be closely monitored through laboratory tests and assessments to track event-free survival up to two years after enrollment. Other outcomes include remission rates, measurable residual disease status, overall survival, relapse-free survival, and short-term mortality rates. The study includes physical status evaluations, echocardiograms, and ongoing safety monitoring throughout the treatment and follow-up periods.

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML