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

Summary

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.

Eligibility

Inclusion Criteria:

* Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; 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 have 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：

* Patients who still require hormonal maintenance therapy after achieving remission.
* Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.
* Having participated in other clinical trials within 1 month prior to screening.
* Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.
* Having other uncontrolled diseases that the investigator deems unfit for enrollment.
* Patients with psychiatric disorders or those known/suspected to be unable 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 safety risk to the subject.

Withdrawal Criteria：

* 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 chemotherapy delay of more than 4 weeks due to adverse reactions.
* Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of \> 10%; or QTc prolongation meeting the following criteria: ① QTc \> 500 ms; ② QTc \> 530 ms in patients 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 treatment.

Conditions4

Interventions1

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