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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
UCLA School of Medicine
Los Angeles, California, United States
Rocky Mountain Blood & Marrow Transplant Program
Denver, Colorado, United States
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
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.
Time frame: 1 year
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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
...and 8 more locations