Daunorubicin + Cytarabine + Venetoclax in de Novo AML

Sponsor
Anhui Medical University
Study ID
NCT06697327
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • (Daunorubicin, Cytarabine, Venetoclax) — DRUG
    * 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) — DRUG
    * 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

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
May 2025
Primary completion
Aug 1, 2025
Completion
Aug 1, 2026

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment(Daunorubicin, Cytarabine, Ventoclax)
    Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.
  • Active Comparator: Control(Daunorubicin, Cytarabine)
    Control(Daunorubicin, Cytarabine) See Detailed Description.

Primary Outcome Measure

Overall response rate [ Time Frame: End of cycle 2 (each cycle is 14 days) ]

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