Study of GSK2130579A Tumor-Antigen-Specific Cancer Immunotherapeutic in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
- The patient has cytologically proven AML, as defined by the 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
- The patient received the following therapy according to the Institution's standard of
- For patients < 60 years old: at least two induction chemotherapy treatments.
- For patients >= 60 years old: at least one induction chemotherapy treatment or
- The first ASCI administration should be given within 70 days (ten weeks) after the
last chemotherapy 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 (as defined
by "Recommendations of the International Working Group for Diagnosis, Standardization
of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic
Trials in Acute Myeloid Leukemia" [Cheson, 2003]):
- Partial Remission (PR) i.e.
- A decrease of at least 50% in the percentage of blasts to 5% - 25% in the bone marrow
aspirate following chemotherapy.
- In case the bone marrow contains <= 5% blasts, the presence of Auer rods also
indicates a partial remission.
- Neutrophil count >= 1,000/μl
- Platelet count >= 100,000/μl
- The patient is independent of red blood cell transfusions
- Morphologic complete remission with incomplete blood count recovery (CRi) i.e.
patients fulfil all criteria of the morphological CR except for:
- Neutrophil count <1,000/μl. and/or
- Platelet count <= 100,000/μl. However, for the purpose of this clinical protocol
platelet levels must be > 50,000/μl.
- Written informed consent has been obtained prior to the performance of any
- The patient is >= 18 years of age at the time of signature of the first informed
- Eastern Cooperative Oncology Group performance status of 0, 1 or 2 at the time of
- Adequate hepatic and renal function defined as:
- Serum bilirubin < 1.5 times the Upper Limit of Normal (ULN).
- Serum ALT < 2.5 times the ULN.
- 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, 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
- The patient has acute promyelocytic leukemia with t(15;17) (q22;q12), (PML/RARα) or
- The patient has received, is receiving -or is due to receive- allogeneic SCT.
- The patient has received Fludarabine, Clofarabine or Cloretazine within 12 months
preceding the ASCI treatment.
- 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 inflammatory bowel disease. Patients with vitiligo are not
- 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 problems, 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 or previous myocardial
- The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent, or to comply with the trial procedures.
- The patient has received any investigational or non-registered medicinal product
other than the study treatment 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 immunosuppressive agents.
- Note: 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 is receiving full dose subcutaneous heparins or is under anti-coagulation
treatment (e.g. phenprocoumon).
- For female patients: the patient is pregnant or lactating.