The hypothesis that CPX-351 treatment may be safe and efficacious in patients with newly diagnosed secondary AML comes from a single randomized Phase II study which observed significant improvement in survival in a 52-patient subset of patients with secondary AML. A Phase III confirmatory study has recently completed accrual and final results are not expected until mid-2016. Therefore, the sponsor has chosen to make CPX-351 available to secondary AML patients through this expanded access protocol until commercialization of CPX-351 or more information about the clinical utility is known.~This study is a Phase IV multicenter, single-arm open-label Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy. Patients may receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, serious adverse events, grade 3 and 4 adverse events, etc.) while on the study and for SAEs for 30 days after the last dose of CPX-351. Study enrollment will be available through commercialization of CPX-351.
This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.