Clolar clofarabine: Phase III data

The double-blind, international Phase III CLASSIC I trial in 326 relapsed or refractory AML patients ages 55 and older showed that Clolar plus cytarabine missed the primary endpoint of significantly improving OS vs. placebo plus cytarabine. Clolar plus cytarabine did meet the 4 secondary endpoints of significantly improving overall remission rate (47% vs. 23%, p=0.0001), complete remission rate (p=0.0004), EFS (p=0.0001), and 4-month EFS (p=0.0001) vs. placebo. ...