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.

Conditions

• Acute Myeloid Leukemia
• Personalized Active Immunotherapy
• Maintenance Therapy

Interventions

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.

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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital

  lead OTHER

Principal Investigators

• Meijuan Huang · Fujian Institute of Haematology, Fujian Medical University Union Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2026-09-01

Completion

2026-09-01

Countries

• China

Study Locations