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

Phase 2

Terminated

• Conditions: Leukemia
• Interventions: Drug: AEG35156

• Registration Number: NCT01018069
• Lead Sponsor: Aegera Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-12
• Last Update Posted: 2011-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AEG35156	AEG35156	Patient receive AEG35156 prior to chemotherapy
Control	AEG35156	Patients receive chemotherapy only

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH; 🇩🇪 Kiel, Germany

Rocky Mountain Blood & Marrow Transplant Program; 🇺🇸 Denver, Colorado, United States

MD Anderson Cancer Center University of Texas; 🇺🇸 Houston, Texas, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Northwestern University Med School, div. Oncology & Hematology; 🇺🇸 Chicago, Illinois, United States

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Charles Lemoyne; 🇨🇦 Greenfield Park, Quebec, Canada

Hopital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Hopital Sacre Coeur; 🇨🇦 Montreal, Quebec, Canada

St. Johannes Hospital; 🇩🇪 Duisburg, Germany

Cancer Research Institute of Scott & White Hospital; 🇺🇸 Temple, Texas, United States

Universitatsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitatsklinimum Essen; 🇩🇪 Essen, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Robert Boasch Krankenhaus Stuttgart; 🇩🇪 Stuttgart, Germany

III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat; 🇩🇪 Mainz, Germany

Medizinische Klinik a Hamatologie und Onkologie; 🇩🇪 Munster, Germany

New York Medical College; 🇺🇸 Valhalla, New York, United States