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

In this study, patients were to receive a maximum of 24 doses of WT1 ASCI according four
cycles over a period of four years.

This protocol summary has been updated according to the Protocol Amendment 6 (dated 10 Sept
2014).

There will no longer be an active follow-up of patients after discontinuation or completion
of the treatment. The study will end 30 days after the last dose will be administered, so the
patients will not be further exposed to unnecessary study related procedures.. In addition,
no more biological samples will be collected for protocol research purposes. For each
biological sample already collected in the scope of this study and not tested yet, testing
will not be performed by default, except if a scientific rationale remains relevant. Blood
sampling for safety monitoring as per protocol will continue.

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 < 1.5 times the Upper Limit of Nor-mal (ULN).

- Serum alanine aminotransferase < 2.5 times the ULN.

- Calculated creatinine clearance > 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.