drugset / Trial / NCT06697327

Daunorubicin + Cytarabine + Venetoclax in de Novo AML

NCT06697327

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a non-profit, prospective, single-center, open-label, controlled clinical trial aimed at evaluating the efficacy of the daunorubicin, cytarabine, and venetoclax (DAV) regimen in previously untreated adult AML patients eligible for intensive chemotherapy.The combination of daunorubicin administered for 3 consecutive days and cytarabine for 7 consecutive days constitutes the classic "3+7" induction chemotherapy regimen for AML patients eligible for chemotherapy. The addition of venetoclax to the "3+7" regimen has shown promising efficacy in newly diagnosed AML patients suitable for intensive therapy. However, this approach is associated with increased adverse reactions. Based on current clinical studies, we propose a modified approach involving reduced-dose chemotherapy combined with venetoclax for AML treatment, aiming to achieve optimal efficacy while effectively reducing adverse reactions.

Timeline

Start
2025-02-01
Primary completion
2025-08-01
Completion
2026-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 100 mg/m2
Subject Daunorubicin Small molecule 40 mg/m2
Subject Daunorubicin Small molecule 60 mg/m2
Subject Venetoclax Small molecule 400 mg