DC Vaccination for Post-remission Therapy in AML

• Diagnosis of Acute Myeloid Leukemia (AML)
• Age 18 - 75 years
• Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
• WT1 with or without PRAME positivity by qPCR
• Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
• Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
• Informed consent signed prior to any trial related activities

Exclusion Criteria:

• Patients suitable for allogeneic stem cell transplantation
• AML M3 (acute promyelocytic leukemia)
• Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
• Active immunodeficiency syndromes
• Concurrent active second malignancy other than non-melanoma skin cancers
• Clinically relevant autoimmune disease
• Prior immunotherapy
• Severe organ dysfunction precluding the apheresis procedure:
• Creatinine > 200 mmol/l
• Bilirubin, ALAT and ASAT > 3 x upper normal limit
• Respiratory insufficiency with pO2 \< 60 mmHg
• Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure > grade II NYHA
• Recent cerebral hemorrhage
• Known allergies to substances used in the generation of DCs
• Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
• Use of corticosteroids
• Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
• Inability to comply with the trial protocol
• Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial