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

NCT01018069 | Terminated Phase 2

• 2 other identifiers: AEG35156-2062009-013669-25
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 18

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

Keywords

Acute; myeloid; leukemia; antisense; chemotherapy; idarubicin; cytarabine; Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

AEG35156

ACTIVE COMPARATOR

Patient receive AEG35156 prior to chemotherapy

Drug: AEG35156

Control

SHAM COMPARATOR

Patients receive chemotherapy only

Drug: AEG35156

Interventions

AEG35156 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.

AEG35156; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aegera Therapeutics: lead

Study Sites (18)

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Rocky Mountain Blood & Marrow Transplant Program

Denver, Colorado, 80218, United States

Location

Northwestern University Med School, div. Oncology & Hematology

Chicago, Illinois, 60611, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

MD Anderson Cancer Center University of Texas

Houston, Texas, 77303, United States

Location

Cancer Research Institute of Scott & White Hospital

Temple, Texas, 76502, United States

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Hopital Sacre Coeur

Montreal, Quebec, Canada

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

Location

St. Johannes Hospital

Duisburg, 47166, Germany

Location

Universitatsklinimum Essen

Essen, 45147, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH

Kiel, 24116, Germany

Location

III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat

Mainz, 55131, Germany

Location

Medizinische Klinik a Hamatologie und Onkologie

Münster, 48129, Germany

Location

Robert Boasch Krankenhaus Stuttgart

Stuttgart, 70376, Germany

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Promyelocytic, Acute

Interventions

AEG 35156

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Leukemia, Myeloid

Study Officials

• Aaron Schimmer, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

US (6); DE (8); CA (4)