The primary aim of this innovative immunotherapy using WT1/hTERT/Survivin-loaded DCs is to determine whether this novel DC vaccination is safe and can significantly prevent clinical relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease, while maintaining its safety profile in this phase I trial.
Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
Patients completed induction and consolidation chemotherapy and have achieved complete remission (CR) by bone marrow biopsy criteria but with persistent MRD (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) and are not eligible for stem cell transplant
Patients have MRD molecular relapse (defined by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after achieved CR following induction and consolidation chemotherapy.
Patients with molecular relapse (define by upregulated WT1 level and less than 5% of blast cells in bone marrow biopsy) after allogeneic stem cell transplant
Participation in any other interventional clinical trial during the study period.
History or concomitant presence of any other malignancy, except for any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment.
Patients with a second invasive malignancy requiring treatment within the last 2 years are not eligible.
Patients with any form of systemic immunodeficiency, including AIDS or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment.
Single group
DC vaccine
Biological/VaccineAutologous/or HLA-matched donors' DCs loaded with WT1/TERT/survivin
the Incidence of Treatment Adverse Events
To determine the safety of autologous/or HLA-matched DCs loaded with WT1/TERT/Survivin. The primary objective of this single-arm phase I clinical study is to determine the safety and feasibility of WT1/TERT/survivin-targeted DC vaccination in adult AML patients with MRD at very high risk of relapse.
OS
Overall survival
Complete MRD response rate
To determine the Complete MRD response rate
Relapse rate
(time frame: at study completion, an average of 5 year)
Relapse-free survival
(time frame: at study completion, an average of 5 year)
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