Clinical Trial

Daunorubicin + Cytarabine + Venetoclax in de Novo AML

Enrolling by Invitation
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Record status
This record was last updated May 14, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-18.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-05-10
Trial Details
NCT Number NCT06697327
Lead Sponsor Anhui Medical University
Collaborators: The First Affiliated Hospital of Anhui Medical University
Conditions Leukemia, Myeloid, Acute, Acute Myeloid Leukemia
Enrollment 94 participants
Start Date 2025-02-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-14