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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 courses of routine consolidation chemotherapy | No Intervention | 6 courses of routine consolidation chemotherapy | |
| Active immunotherapy administered during 6 courses of routine consolidation chemotherapy | Experimental | Active immunotherapy administered during 6 courses of routine consolidation chemotherapy |
|
| Active immunotherapy administered after 6 courses of routine consolidation chemotherapy | Experimental | Active immunotherapy administered after 6 courses of routine consolidation chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Immunotherapy | Biological | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meijuan Huang | Contact | 13365910912 | huangmj@fjmu.edu.cn | |
| Shuxia Zhang | Contact | 86-18006908855 | zhangshuxia235@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Meijuan Huang | Fujian Institute of Haematology, Fujian Medical University Union Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| after 6 courses of routine consolidation chemotherapy | Other | 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. |
|
| during 6 courses of routine consolidation chemotherapy | Other | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| ID | Term |
|---|---|
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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