Autologous peptide vaccine as maintenance therapy for AML

A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)

This study tests whether a personalized vaccine made from a patient's own peptides can help prevent relapse in adults with acute myeloid leukemia who are in remission and receiving consolidation/maintenance chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07551037 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional study delivering autologous peptide-induced active immunotherapy to adult AML patients who achieved remission after induction and are receiving routine consolidation/maintenance chemotherapy. Patients receive the peptide immunotherapy in conjunction with their consolidation courses to determine safety and early signs of immune activity and clinical benefit. The trial enrolls adults aged 18–70 with recovered blood counts and an expected survival of at least 12 months. Primary focus is on tolerability and safety, with secondary observations on immune responses and relapse rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–70 with newly diagnosed AML who achieved remission after 1–2 courses of chemotherapy, have largely recovered blood counts, are on routine consolidation/maintenance therapy, and are expected to live at least 12 months.

Not a fit: Patients who require ongoing hormonal maintenance, have active or uncontrolled other malignancies, recent participation in another trial, uncontrolled comorbid conditions, or fall outside the age or recovery criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could offer a well-tolerated maintenance option that lowers relapse risk and improves long-term survival without major liver or kidney toxicity.

How similar studies have performed: Personalized neoantigen and peptide vaccines have produced promising immune responses in early-phase studies across cancers, but definitive clinical benefit in AML remains unproven and is still under investigation.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Meijuan Huang

Conditions Acute Myeloid Leukemia; Personalized Active Immunotherapy; Maintenance Therapy