Acute Myeloid Leukemia Clinical Trial
Official title:
Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
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.
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