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

NCT07642453 | Not Yet Recruiting Phase 2

• 1 other identifier: km-09
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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.

Conditions

Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (1)

• CR rate

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

Secondary Outcomes (3)

• Adverse Events

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

• Duration of remission

  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)

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

Other Outcomes (2)

• Overall survival

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

• Relapse-free survival

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

Study Arms (2)

2-week VACAG regimen for newly diagnosed acute myeloid leukemia

EXPERIMENTAL

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.

3-week VACAG regimen for newly diagnosed acute myeloid leukemia

ACTIVE COMPARATOR

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.

Interventions

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

Specific Medication for the VACAG Protocol: 1. 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; 2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.

2-week VACAG regimen for newly diagnosed acute myeloid leukemia; 3-week VACAG regimen for newly diagnosed acute myeloid leukemia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hematology department of the 920th hospital: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wang sanbin

CONTACT

13187424131; 1739701184@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06