drugset / Trial / NCT06635681

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

NCT06635681

NaSingle-groupOpen-labelTreatment

Summary

Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients. Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival. Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy. Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.

Timeline

Start
2024-09-29
Primary completion
2026-12-01
Completion
2028-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 400 mg
Background Azacitidine Other / unclassified 75 mg/m2
Background Cytarabine Small molecule 2 g/kg
Background Daunorubicin Small molecule 60 mg/m2