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Daunorubicin + Cytarabine + Venetoclax in de Novo AML

NCT06697327 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Anhui Medical University

    lead OTHER

Principal Investigators

  • ZhangBiao Long, Doctor · Department of Hematology, The First Affiliated Hospital of Anhui Medical University, 218 Jixi Road

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697327 on ClinicalTrials.gov