Celator Pharmaceuticals has commenced patient enrollment in the phase-III study of CPX-351 in untreated high-risk acute myeloid leukemia (AML).
The open-label trial is designed to assess CPX-351 (cytarabine:daunorubicin) liposome injection compared to cytarabine and daunorubicin therapy (7+3) as first-line therapy in high risk (secondary) AML patients 60-75 year old.
Celator chief medical officer Arthur Louie said, "Clinical studies completed to date suggest that CPX-351 may provide an opportunity to improve outcomes in AML, particularly for high-risk patients whose prognosis on standard therapy is poor."
Patients who have pathological diagnosis of AML based on WHO criteria, with confirmation of therapy-related AML, AML with a history of myelodysplasia (MDS), AML with a history of chronic myelomonocytic leukemia, De novo AML with karyotypic abnormalities characteristic of MDS will participate in the study.
Subjects will be randomized with either CPX-351 (100u/m2; days one, three, and five by 90 minute infusion) or 7+3 (cytarabine 100mg/m2/day by continuous infusion for seven days and daunorubicin 60mg/m2 on days one, two, and three) in 1:1 ratio and will be assessed for clinical adverse events in addition to laboratory evaluations.
Overall survival is the primary efficacy endpoint of the multicenter study scheduled to be conducted in the US and Canada.
Celator chief executive officer Scott Jackson said, "The initiation of this study is an important milestone for CPX-351 and for Celator. We hope the data it provides will allow us to seek regulatory approval for CPX-351 and, ultimately, make an important and much-needed treatment option available to patients with AML."
The company is conducting the study in collaboration with The Leukemia & Lymphoma Society (LLS), which supported the CPX-351 development through its Therapy Acceleration Program.