Evaluation of a New Anti-cancer Immunotherapy After Chemotherapy in Adult Patients With Acute Myeloid Leukemia (AML)
Condition: Leukaemia, Myelocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI)
Intervention description: Intramuscular administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; ASCI; Complete remission; Immunotherapy; adult; Acute Myeloid Leukemia; Tumor antigen; WT1

Summary:

      This study is being done to evaluate the safety of a WT1 Antigen-Specific Cancer
      Immunotherapeutic (WT1 ASCI) as post-consolidation therapy in adult patients with
      WT1-positive Acute Myeloid Leukemia in first complete remission. It will also be analyzed to
      what extent this treatment induces an immune response, specific to the malignancy.
    

Eligibility criteria:

        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.