Phase 2 study of CPX-351 for the treatment of acute myeloid leukemia (AML)
Celator announced the completion of enrollment for its Phase 2 study of CPX-351 (cytarabine and daunorubicin) Liposome Injection for the treatment of adult patients with acute myeloid leukemia (AML). This trial is a multicenter, randomized, open-label clinical trial comparing CPX-351 with intensive salvage therapy in patients between the ages of 18 and 65 who had pathological confirmation of relapsed AML after an initial complete response to prior therapy lasting at least one month. The primary efficacy endpoint of the study is the comparison of overall survival at 1 year between the study's two treatment arms. Secondary endpoints include complete remission (CR) rate and duration, 30, 60, and 90-day mortality, event-free survival, aplasia rate, and rate of transfer for stem cell transplant.
CPX-351 is a combination of two drugs with synergistic anti-tumor activity (cytarabine and daunorubicin); these drugs are encapsulated in a liposome injection drug delivery vehicle in order to maintain the desired drug molar ratio following administration.
For more information call (609) 243-0123 or visit www.celatorpharma.com.