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

NCT ID: NCT01018069

Last Updated: 2011-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-10-31

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.

Conditions

Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AEG35156

Patient receive AEG35156 prior to chemotherapy

Group Type: ACTIVE_COMPARATOR

AEG35156

Intervention Type: DRUG

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.

Control

Patients receive chemotherapy only

Group Type: SHAM_COMPARATOR

AEG35156

Intervention Type: DRUG

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.

Interventions

AEG35156

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.

Intervention Type: DRUG

Eligibility 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 < 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aegera Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Aegera Therapeutics Inc.

Principal Investigators

Aaron Schimmer, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

UCLA School of Medicine

Los Angeles, California, United States

Rocky Mountain Blood & Marrow Transplant Program

Denver, Colorado, United States

Northwestern University Med School, div. Oncology & Hematology

Chicago, Illinois, United States

New York Medical College

Valhalla, New York, United States

MD Anderson Cancer Center University of Texas

Houston, Texas, United States

Cancer Research Institute of Scott & White Hospital

Temple, Texas, 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

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

St. Johannes Hospital

Duisburg, , Germany

Universitatsklinimum Essen

Essen, , Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , Germany

2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH

Kiel, , Germany

III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat

Mainz, , Germany

Medizinische Klinik a Hamatologie und Onkologie

Münster, , Germany

Robert Boasch Krankenhaus Stuttgart

Stuttgart, , Germany

Countries

United States; Canada; Germany

Other Identifiers

2009-013669-25

Identifier Type: REGISTRY

Identifier Source: secondary_id

AEG35156-206

Identifier Type: -

Identifier Source: org_study_id