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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia (AML)
• Intervention / Treatment: Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wang sanbin; Phone Number: 13187424131; Email: 1739701184@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;
2. Age 18-75 years;
3. Body weight 30-100 kg;
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;
5. 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);
6. No severe infections;
7. Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2-week VACAG regimen for newly diagnosed acute myeloid leukemia; Specific Medication for the 2-week VACAG regimen Protocol: 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, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;	Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.; 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.
Active Comparator: 3-week VACAG regimen for newly diagnosed acute myeloid leukemia; Specific Medication for the 3-week VACAG regimen Protocol: 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 3-21, 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, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;	Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CR rate	At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.	From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）
Duration of remission	DOR was defined as the period from the time to acquire CR until relapse	From the date of the first remission until the date of relapse (assessed up to 30 months)
Minimal Residual Disease negative remission rate (MRD-negative rate)	Percentage of participants who converted to MRD < 10^-3 by flow cytometry before initiation of consolidation therapy.	After 1 cycle of induction (each cycle is about 30 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall Survival will be defined as the time from administration of the initial doses until death from any cause.	From the first day of induction until the date of death from any cause, assessed up to 30 months.
Relapse-free survival	Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.	From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months.

Collaborators and Investigators

• Sponsor: Hematology department of the 920th hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; venetoclax
• Other Study ID Numbers: km-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No