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Daunorubicin + Cytarabine + Venetoclax in de Novo AML
Sponsor: Anhui Medical University
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.
Official title: Daunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2025-02-01
Completion Date
2026-08-01
Last Updated
2025-05-14
Healthy Volunteers
No
Interventions
(Daunorubicin, Cytarabine, Venetoclax)
* Drugs:Daunorubicin * Dosage: 40 mg/(m²·d) on days 1 to 3 * Other names: Cerubidine, Daunomycin, Rubidomycin * Drugs:Cytarabine * Dosage: 100 mg/(m²·d) on days 1 to 5 * Other names: Ara-C, Cytosine Arabinoside, Cytosar-U * Drugs:Venetoclax * Dosage: 100 mg on day 1, 200 mg on day 2, and 400 mg from days 3 to 14 * Other names: ABT-199, Venclexta, Venclyxto
(Daunorubicin, Cytarabine)
* Drugs:Daunorubicin * Dosage: 60 mg/(m²·d) on days 1 to 3 * Other names: Cerubidine, Daunomycin, Rubidomycin * Drugs:Cytarabine * Dosage: 100 mg/(m²·d) on days 1 to 7 * Other names: Ara-C, Cytosine Arabinoside, Cytosar-U
Locations (1)
Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road
Hefei, Anhui, China