To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
309
First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.
First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3. Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2. Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Overall Survival
Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
Time frame: From the date of randomization to death from any cause
Proportion of Subjects With a Response
Complete Remission (CR)
Time frame: Post Induction
Event-free Survival
All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
Time frame: From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first
Remission Duration
Only subjects achieving CR or CRi were assessed for remission duration.
Time frame: From the date of achievement of a remission until the date of relapse or death from any cause
Rate of Achieving Morphologic Leukemia-free State
All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.
Time frame: Day 14
Proportion of Subjects Receiving a Stem Cell Transplant
The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
University of CA San Diego
San Diego, California, United States
Stanford University
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
...and 33 more locations
Time frame: Post Induction