Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission

Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).

  * all French-American-British (FAB) subtypes, except:

    \- M3 (acute promyelocytic leukemia)
  * all cases of de novo AML or secondary AML with ≥ 20 % blasts in peripheral blood and/or bone marrow, except:

    * AML secondary to myeloproliferative neoplasms (MPN)
    * AML secondary to exposure of leukemogenic agents (t-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax.
* Completion of one of the following treatment options:

  * I) Intensive chemotherapy:

    * (1) at least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR
    * (2) one to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment OR
  * II) Low-intensity chemotherapy:

    * (3) at least two cycles to maximum six cycles of hypomethylating agents whether or not combined with venetoclax OR
    * (4) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax;
  * resulting in:

    * morphological complete remission (CR), i.e. bone marrow blast count \<5% with neutrophil count \>1000 cells/µL and platelet count \>100,000 cells/µL OR
    * morphological complete remission with incomplete blood recovery (CRi), i.e. bone marrow blast count \<5% with neutrophil count \<1000 cells/µL or platelet count \<100,000 cells/µL.

For the purpose of this study protocol, platelet count must be \>50,000 cells/µL.

* Adult (≥ 18 years) at very high risk of relapse according to:

  * Age ≥ 60 years, and/or
  * Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (\> 100000 cells/µL)), and
  * Ineligible for or unwilling to receive hematopoietic stem cell transplantation.
* WHO performance status: grade 0, 1 or 2 at the time of enrollment. For definition of performance status, see: http://www.ecog.org/general/perf\_stat.html
* Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry.

Exclusion Criteria:

* Participation in any other interventional clinical trial during the study period.
* History or concomitant presence of any other malignancy, except for:

  * non-melanoma skin cancer
  * carcinoma in situ of the cervix
  * 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.
* Concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo.
* Concomitant use of systemic corticosteroids in immunosuppressive doses (\>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection.
* Pregnant or breast-feeding