Acute myeloid leukemia after failure of a single standard dose cytarabine based frontline induction regimen. MedDRA version: 12.0 Level: LLT Classification code 10001941 Term: AML
Conditions
Interventions
Product Name: AEG35156
Product Code: AEG35156
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: d(P-thio)[(2'-O-Me)(rU-rG-rC-rA)-C-C-C-T-G-G-A-T-A-C-C-(2'-O-Me)(rA-rU-rU-rU)]
Sponsors
Aegera Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. - Patients who have previously been enrolled into this study and subsequently withdrawn must also be excluded. Both men and women and members of all races and ethnic groups are eligible for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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. - To determine if AEG35156 can enhance response duration following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.;Secondary Objective: - To determine if AEG35156 can enhance overall survival following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. - To determine the safety of adding AEG35156 to high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. - To study the pharmacokinetics of AEG35156 when used in combination with cytarabine and idarubicin;Primary end point(s): - 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. - To determine if AEG35156 can enhance response duration following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen. | — |
Countries
Germany
Outcome results
None listed