Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

Inclusion Criteria:

* Patients with AML, in second complete remission of AML (all FAB-subclasses), not eligible for additional intensification therapies e.g. allogeneic (allo) PSCT \[independent of age\]; OR
* Patients with relapse (smouldering) AML not eligible for additional intensification therapies e.g. alloPSCT; OR
* Patients with de novo (smouldering) AML not eligible for intensive treatment according to current HOVON trials.
* Patients \>65 years of age with de novo AML in first CR and off protocol of current HOVON trials.
* WHO performance of 0, 1, or 2.
* Male or female patients at least 18 years of age and \<80 years by date of enrolment.
* Patients not treated within current HOVON or other AML trials.
* Ability and willingness to give informed consent.
* HLA-A2.1 positive patients (only for cohort 4).

Exclusion Criteria:

* Uncontrolled active infection.
* Previous immunotherapy in last 3 months (except for anti-CD33 targeted therapy).
* Previous allogeneic PSCT.
* Inadequate bone marrow function: absolute neutrophile count (ANC) \< 0.5x10E9/L, or platelet count \< 20x10E9/L or active bleeding with platelet count \> 20x10E9/L.
* Inadequate liver function, defined as:

  * Serum (total) bilirubin \> 1.5 x the upper limit of normal (ULN)
  * AST/SGOT or ALT/SGPT \> 2.5 x ULN
  * Alkaline phosphatase levels \> 2.5 times the ULN at baseline.
* Inadequate renal function, defined as:

  * Serum creatinine \> 1.5 x ULN
* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
* Women of childbearing potential (defined as \< 2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly).
* Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
* Minor surgical procedures, within 24 hours prior to the first study treatment.
* Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within ≤ 6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication.
* Known hypersensitivity to any of the study drugs or excipients.
* Evidence of an other medical condition (such as psychiatric illness, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
* Eligibility for the HOVON-93 study (intensification program ± allogeneic stem cell transplant).