Phase II, multicenter, randomized, open label trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus cytarabine and daunorubicin in patients with untreated AML 60-75 years of age.
CPX-351 is a liposomal formulation of cytarabine:daunorubicin designed to deliver synergistic drug ratios to leukemia cells. In this Phase II study newly diagnosed older AML patients were randomized 2:1 to first-line CPX-351 or 7+3 treatment. The goal was to determine efficacy and identify patient subgroups that may benefit from CPX-351 treatment. Response rate (CR+CRi) was the primary endpoint, with event-free survival (EFS) and overall survival (OS) as secondary endpoints. The 126 patients entered were balanced for disease and patient-specific risk factors. Overall, CPX-351 produced higher response rates (66.7%vs.51.2%, P=0.07), meeting predefined criteria for success (P<0.1). Differences in EFS and OS were not statistically significant. A planned analysis of the secondary AML subgroup demonstrated an improved response rate (57.6% vs.31.6%, P=0.06), and prolongation of EFS (HR=0.59, P=0.08) and OS (HR=0.46, P=0.01). Recovery from cytopenias was slower following CPX-351 (median days to ANC≥1000: 36vs.32; Platelets >100K: 37vs.28) with more grade 3-4 infections but without increase in infection-related deaths (3.5%vs.7.3%) or 60-day mortality (4.7% vs.14.6%) indicating acceptable safety. These results suggest clinical benefit with CPX-351, particularly among patients with secondary AML and provide the rationale for a Phase III trial currently underway in newly diagnosed secondary AML patients. This study was registered at Clinicaltrials.gov, identifier: NCT00788892.
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.