Randomized Study Comparing Venetoclax with Decitabine and Modified Chemotherapy Regimens Versus Standard Chemotherapy in Adults with Newly Diagnosed Acute Myeloid Leukemia

What this Trial Is About

This research aims to evaluate and compare three intensive induction treatment regimens involving venetoclax combined with chemotherapy drugs in adult patients newly diagnosed with acute myeloid leukemia AML who are fit for intensive therapy. The trial is a phase 3, randomized, open-label study designed to identify the optimal use of venetoclax to improve remission rates while maintaining tolerability. It includes around 291 adults aged 16 to 65 with AML, excluding certain favorable subtypes and those previously treated for AML. Participants are randomly assigned to one of three treatment groups Arm A receives venetoclax plus a modified 26 daunorubicin and cytarabine regimen Arm B receives venetoclax with a 3-day decitabine course and additional targeted drugs for some patients Arm C receives the standard 37 daunorubicin and cytarabine chemotherapy. After induction, consolidation therapy includes venetoclax combined with cytarabine for Arms A and B and high-dose cytarabine for Arm C, followed by maintenance therapy with venetoclax plus azacitidine for Arms A and B and azacitidine alone for Arm C. During the study, participants undergo regular assessments including measurable residual disease tests using flow cytometry and sequencing to evaluate treatment response. Researchers measure complete remission rates after induction and monitor overall survival, relapse-free survival, event-free survival, and safety for up to 100 months. The study uses randomized allocation with stratification across multiple centers, and participants are followed through induction, consolidation, maintenance, and long-term outcome evaluation.

DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML