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.

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.