aeg35156 in combination with high-dose cytarabine and idarubicin in aml following failure of a single standard dose cytarabine based frontline induction regimen

Conditions: Leukemia

Summary: to determine if aeg35156 can enhance the combined complete remission (cr) and cr with incomplete platelet recovery (crp) rate of high-dose cytarabine and idarubicin in aml following failure of a single standard dose cytarabine based frontline induction regimen.


Eligibility criteria:
inclusion criteria: * patients with aml, except those with apl (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. the diagnosis of refractory aml is based on the presence of either \> 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (hb \< 10 g/dl, or platelets \< 100 x 109/l, or neutrophil count \< 1.0 x 109/l). * patients must have an eastern cooperative oncology group (ecog) performance status of ≤2. * male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile. * patients must have adequate organ and immune function as indicated by the following laboratory values: parameter laboratory values serum creatinine; ≤2.0 mg/dl (≤ 177 μmol/l total bilirubin ≤2.0 mg/dl (≤ 34 μmol/l) ast (sgot) and alt (sgpt) ≤3 x uln * the patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions. exclusion criteria: * clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy * patients with a prior history of peripheral neuropathy of grade 2 or higher. * clinical evidence of active cns leukemic involvement. * active and uncontrolled infection. patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study. * current evidence of invasive fungal infection (blood or tissue culture). * current evidence of an active second malignancy except for non-melanoma skin cancer. * uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment. * neurological or psychiatric disorders that would interfere with consent or study follow-up. * known or suspected intolerance or hypersensitivity to the study drugs \[or closely related compounds\] or any of their stated ingredients. study drugs being the antisense, cytarabine and idarubicin. * history of alcohol or other substance abuse within the last year. * use of another investigational agent within the last 14 days prior to enrolment. patients who have received a previous antisense agent in the last 90 days will be excluded. * female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.

Keywords: acute myeloid leukemia antisense chemotherapy idarubicin cytarabine patients with aml, except those with apl (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen.