Leukemia
Conditions
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.
Brief 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.
Interventions
DRUGAEG35156
2 hr infusion of 650 mg of AEG35156 on days 1, 2, 3 and 8. Idarubicin 12 mg/m2 over 30 minutes daily on each of days 4, 5 and 6. The dose of cytarabine will be 1.5 g/m2 daily by continuous infusion x 4 days (days 4-7) in patients under age 65 and x 3 days (days 4-6) in patients age 65 and above.
Sponsors
Aegera Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if AEG35156 can enhance the CR and CR with incomplete platelet recovery (CRp) rate and duration of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine if AEG35156 can enhance overall survival, is safe and measured (Pharmacokinetic) following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. | 1 year |
Countries
Canada, Germany, United States
Outcome results
None listed