The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens. The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment. Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Proportion of Subjects Surviving at 1 Year
The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
Time frame: Up to 1 year from randomization
Complete Remission Rate
Time frame: Following 1st induction, following 2nd induction if applicable
Event Free Survival
Progression EFS median
Time frame: Up to 1 year from randomization
Remission Duration
Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.
Time frame: Following achievement of CR and up to 1 year from randomization
Rate of Aplasia
Patients with Aplasia During Study
Time frame: Up to 1 year from randomization
Rate of Stem Cell Transplant
Number of patients transferred for stem cell transplant
Time frame: Up to 1 year from randomization
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Arizona Cancer Center
Tucson, Arizona, United States
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Northwestern University Robert H. Lurie Comprehensive Cancer Center
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...and 32 more locations