Evaluation of a new anti-cancer immunotherapy in adult Acute Myeloid Leukemia patients with a suboptimal clinical response to induction chemotherapy

The patient has cytologically proven AML as defined by the World Health Organization (WHO) classification. The pretreatment AML karyotype should be documented.

• The leukemia is a de novo or secondary AML.
• The patient's blasts cells show expression of WT1 transcript, detected by quantitative Reverse Transcription–Polymerase Chain Reaction (qRT-PCR).The patient received the following therapy according to the Institution's standard of care.

For patients >= 60 years old: at least one induction chemotherapy treatment or alternative treatment.

• The first ASCI administration should be given within one year after the last chemotherapy administration. All screening procedures should be completed within seven weeks before the first ASCI administration.
• In the investigator’s opinion and in compliance with the Institution Hematology Tumor Board’s guidances, the patient should not be eligible for any additional chemotherapy treatment before the ASCI treatment.
• The clinical status of the patient at inclusion is one of the following:

Morphologic complete remission with incomplete blood count recovery (CRi)

• 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 first informed consent form.
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
• Adequate hepatic and renal function defined as:

Calculated creatinine clearance > 50 mL/min.

• In the view of the investigator, the patient can and will comply with the requirements of the protocol.
• 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, then she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test and continue such precautions for 2 months after completion of the treatment administration series.

The patient was diagnosed with leukemic Central Nervous System (CNS) disease (e.g. before chemotherapy) or presents neurological symptoms at baseline suggestive of a CNS involvement.

• The patient has acute promyelocytic leukemia with t(15;17) (q22;q12), (PML/RARα) or variants.
• The patient has received, or is receiving, allogeneic Stem Cell Transplantation (SCT).
• The patient has received Fludarabine, Clofarabine or Cloretazine within 12 months preceding the ASCI treat-ment.
• 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. Patients with vitiligo are not excluded.
• 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 another metastatic cancer disease.
• The patient has a history of congestive heart failure, coronary 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 treat-ment within 30 days preceding the first dose of study treatment or plans to receive such a drug during the study period.
• The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
• The patient is receiving full dose subcutaneous heparins or is under anti-coagulation treatment.
• For female patients: the patient is pregnant or lactating.