NCT01018069TerminatedPhase 2
An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
Aegera Therapeutics18 sites in 3 countries60 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 18
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 ≤
- •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.
Arms & Interventions
AEG35156
Active Comparator
Patient receive AEG35156 prior to chemotherapy
Intervention: AEG35156 (Drug)
Control
Sham Comparator
Patients receive chemotherapy only
Intervention: AEG35156 (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (18)
Loading locations...
Similar Trials
Active, not recruiting
Phase 2
Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic MelanomaMelanomaNCT04417621Novartis Pharmaceuticals134
Active, not recruiting
Phase 2
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host DiseaseChronic Graft-versus-host-diseaseNCT06388564Incyte Corporation130
Completed
Phase 2
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host DiseaseGraft Vs Host DiseaseNCT00035880Abgenix95
Completed
Phase 2
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell LymphomaRefractory Large B-cell LymphomaNCT04002401Kite, A Gilead Company27
Completed
Phase 2
A Study for Participants With Small-Cell Lung CancerSmall Cell Lung CancerNCT01025284Eli Lilly and Company64