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

Official title

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

Overview

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.

Interventions

• Drug Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
  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 s

Primary outcome measures

• CR rate [Time frame: At the end of Cycle 1 of induction (each cycle is about 30 days)]

Secondary outcome measures (3)

• Adverse Events [Time frame: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）]
• Duration of remission [Time frame: 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) [Time frame: After 1 cycle of induction (each cycle is about 30 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07642453 · km-09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗