Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)

Inclusion Criteria

• The patient has cytologically proven AML, as defined by the WHO classification. The pretreatment AML karyotype should be documented.
• The leukemia could be a de novo or secondary AML.
• The patient received induction and consolidation therapy according to the Institution's standard of care.
• The patient's blasts cells show expression of WT1 tran-script, detected by quantitative RT-PCR.
• The patient is in complete remission (i.e. CR1, CR2, …):
• Written informed consent has been obtained prior to the performance of any protocol-specific procedure.
• The patient is >= 18 years of age at the time of signature of the informed consent form.
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
• Adequate hepatic and renal function defined as:
• Serum bilirubin 50 mL/min.
• If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate con-traception for 30 days prior to treatment administration, have a negative pregnancy test and continue such pre-cautions for two months after completion of the treatment administration series.
• In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Exclusion Criteria

• The patient is in morphologic leukemia-free state or in morphologic complete remission with incomplete blood count recovery (CRi).
• The patient has acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) or variants.
• The patient has received, or is receiving induction chemotherapy followed by Stem Cell Transplantation.
• The patient has (or has had) previous or concomitant malignancies, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
• The patient has hypercalcemia.
• The patient is known to be HIV-positive.
• The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease.
• The patient has a history of allergic reactions likely to be exacerbated by any component of the study investigational product.
• The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• The patient has a history of congestive heart failure, cor-onary artery disease or previous myocardial infarction.
• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
• The patient has received any investigational or non-registered medicinal product other than the study medi-cation within 30 days preceding the first dose of study medication or plans to receive such a drug during the study period.
• The patient requires concomitant treatment with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids or topical steroids is permitted.
• The patient has received intravenous administration of antibiotics within 2 weeks prior to first study treatment or oral antibiotics within 1 week prior to first study treatment.
• For female patients: the patient is pregnant or lactating.