Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy

Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate \<40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate \<20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic/nephrotoxic maintenance regimen effective for preventing recurrence. Tumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve "full antigen coverage" personalized active immunity. This study has significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.

Inclusion Criteria: * 1\. Inclusion Criteria (All must be met) Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias, who have received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy; Aged 18 to 70 years; Receiving a maintenance therapy regimen without hormonal agents; Leukocyte and lymphocyte counts having basically returned to the normal range; Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission; Patients who voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Any subject meeting any of the following criteria shall be excluded from the study: Patients who still require hormonal maintenance therapy after achieving remission; Patients with a concomitant history of other malignant tumors, or an uncontrolled malignant tumor history in the past; Having participated in other clinical trials within 1 month prior to screening; Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other such conditions; Having other uncontrolled diseases that the investigator deems unfit for enrollment; Patients with psychiatric disorders or other patients with known or suspected inability to fully comply with the study protocol; Pregnant or lactating women; HIV-infected individuals; Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant risk to the subject. 3\. Withdrawal Criteria Subjects may withdraw from the study at any time for the following reasons: Judged by the investigator to be in the best interest of the subject; Disease progression or initiation of other anti-leukemia therapy; The subject requests to withdraw from the study for any reason at any time; Lost to follow-up; Death; Occurrence of severe chemotherapy-induced toxic reactions, or delay of chemotherapy for more than 4 weeks due to adverse reactions; Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a reduction of \> 10%; or QTc prolongation meeting the following criteria: ① QTc \> 500 ms; ② QTc \> 530 ms if the subject is diagnosed with bundle branch block; Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and/or aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective therapy.