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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Maintenance Therapy; Personalized Active Immunotherapy
• Intervention / Treatment: Biological: Active Immunotherapy; Other: during 6 courses of routine consolidation chemotherapy; Other: after 6 courses of routine consolidation chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Meijuan Huang; Phone Number: 13365910912; Email: huangmj@fjmu.edu.cn
• Study Contact Backup: Name: Shuxia Zhang; Phone Number: 86-18006908855; Email: zhangshuxia235@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Meijuan Huang, MD; Phone Number: 13365910912; Email: huangmj@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 6 courses of routine consolidation chemotherapy
Experimental: Active immunotherapy administered during 6 courses of routine consolidation chemotherapy	Biological: Active Immunotherapy; Personalized tumor vaccines are prepared from the patient's own acute myeloid leukemia (AML) cells and administered via intradermal injection to induce the body to generate a specific anti-leukemia immune response.; Other: during 6 courses of routine consolidation chemotherapy; Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.
Experimental: Active immunotherapy administered after 6 courses of routine consolidation chemotherapy	Biological: Active Immunotherapy; Personalized tumor vaccines are prepared from the patient's own acute myeloid leukemia (AML) cells and administered via intradermal injection to induce the body to generate a specific anti-leukemia immune response.; Other: after 6 courses of routine consolidation chemotherapy; Initiation of active immunotherapy either during the 6 courses of routine consolidation chemotherapy or after the completion of consolidation chemotherapy, based on the patient's treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	subjects survival after treatment are finished	1-year
overall remission rate (ORR)	subjects achieving complete remission (CR) or partial remission (PR) at the end of cycle 1and cycle 2(each cycle is 1 month)	At the end of Cycle 1 and Cycle 12 (each cycle is 1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Response(TTR)	The time from initiation of the study treatment to the first documentation of CR or PR.	1-2months(1-2 courses）
Duratin of Response(DOR)	The time from first documentation of CR to the first documented disease progression or death, whichever occurs first	1-year
Progression-Free Survival(PFS)	The time interval from the start of the study treatment to the first documentation of disease progression or death from any cause,whichever occurs first	1-year

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Investigators: Study Director: Meijuan Huang, Fujian Institute of Haematology, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Investigative Techniques; Therapeutics; Biological Therapy; Immunologic Techniques; Immunomodulation; Immunization; Immunotherapy; Immunotherapy, Active
• Other Study ID Numbers: FJ Depart of Hematology 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No