AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen

Aegera Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Leukemia

Treatments

Drug: AEG35156

Study type

Interventional

Funder types

Industry

Identifiers

NCT01018069

2009-013669-25 (Registry Identifier)

AEG35156-206

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.