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.
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;
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;