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ENROLLING BY INVITATION
NCT06697327
NA

Daunorubicin + Cytarabine + Venetoclax in de Novo AML

Sponsor: Anhui Medical University

View on ClinicalTrials.gov

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

DRUG

(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

DRUG

(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