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

Prior treatment

• 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.

Other

• Participation in any other interventional clinical trial during the study period.
• Pregnant or breast-feeding

• 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.