A Randomized Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial. A total of 320 patients will be enrolled in this study,and segregated into four groups with 80 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
Epistemonikos ID: d26c3ec555e16c7d2ce8856e32bd59017fdee63b
First added on: Aug 11, 2026