US-based Celator Pharmaceuticals has treated the first patient in its Phase II multicenter, randomized, open-label clinical trial of CPX-351 liposome injection versus intensive salvage therapy in adult patients, up to 60 years old, with acute myeloid leukemia in first relapse.
The study will enroll up to 120 patients between the ages of 18 and 60 who have pathological confirmation of relapsed acute myeloid leukemia (AML) after an initial complete response to prior therapy lasting at least one month.
Patients will be randomized (2:1) to receive either CPX-351 or one of several control arm regimens, including high dose cytarabine with or without daunorubicin; conventional ‘7+3’ (cytarabine/daunorubicin regimen); ‘MEC’, the mitoxantrone/etoposide/cytarabine regimen; and other published salvage regimens. Patients will be monitored for all clinical adverse events as well as laboratory evaluations, the company said.
The primary efficacy endpoint of the study is the comparison of overall survival at one year between the two arms. Secondary endpoints include complete remission rate and duration, event-free survival, aplasia rate, and rate of transfer for stem cell transplant. The study will be open for enrollment at leading institutions in the US and Canada.
Scott Jackson, CEO of Celator Pharmaceuticals, said: We are delighted that our second Phase II study of CPX-351 in AML is underway and appreciate the support of LLS and the enthusiasm of our clinical investigators. There has been increasing excitement in the medical community about CPX-351 and we look forward to developing this product for the benefit of patients with AML.