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NCT Number: NCT07642453

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML).

Key Research Questions:

1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML? 2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;
  • Age 18-75 years;
  • Body weight 30-100 kg;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;
  • No significant organ dysfunction (echocardiographic ejection fraction >45%; bilirubin <2 times the upper limit of normal; AST and ALT <3 times the upper limit of normal; serum creatinine <2 times the upper limit of normal);
  • No severe infections;
  • Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

  • Patients with other types of diseases;
  • Patients with a projected survival of less than 1 month;
  • History of prior treatment;
  • Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events;
  • Other circumstances deemed unsuitable for enrollment by the investigator.

Treatment and study plan

Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.

Drug

Specific Medication for the VACAG Protocol:

  • Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
  • Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.

Primary outcomes

  1. CR rate

    Time frame: At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary outcomes

  1. Adverse Events

    Time frame: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）

    Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

  2. Duration of remission

    Time frame: From the date of the first remission until the date of relapse (assessed up to 30 months)

    DOR was defined as the period from the time to acquire CR until relapse

  3. Minimal Residual Disease negative remission rate (MRD-negative rate)

    Time frame: After 1 cycle of induction (each cycle is about 30 days)

    Percentage of participants who converted to MRD < 10^-3 by flow cytometry before initiation of consolidation therapy.

Other outcomes

  1. Overall survival

    Time frame: From the first day of induction until the date of death from any cause, assessed up to 30 months.

    Overall Survival will be defined as the time from administration of the initial doses until death from any cause.

  2. Relapse-free survival

    Time frame: From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months.

    Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.

Study contacts

Contact information is provided by the study sponsor or research team.

Wang sanbin

CONTACT

[email protected]

13187424131

Sponsors and collaborators

Lead sponsor

Hematology department of the 920th hospital

Other

Registry information

Official study title

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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