The Classic I study was a randomised, double-blind, placebo-controlled clinical trial that compared Clolar in combination with cytarabine to cytarabine plus placebo in patients 55 years and older with AML who relapsed or were refractory after receiving up to two prior induction regimens.
The event driven trial was powered to detect at least a 50% improvement in overall median survival in the Clolar plus cytarabine combination arm.
Reportedly, Classic I trial did not show a difference between the arms in the primary endpoint of overall survival.
In the trial, the Clolar combination demonstrated significance across all four pre-specified secondary efficacy endpoints, which are overall remission rate; complete remission rate; event-free survival; and four-month event free survival.
Anderson Cancer Center MD Hagop Kantarjian said that of importance, the Clolar combination doubled the overall remission rate to 47%.
"Also, we see a 37% improvement in event-free survival, a particularly important measure of clinical benefit," Kantarjian said.
Genzyme Transplant, Oncology, and Multiple Sclerosis president Mark Enyedy said that they are collaborating with the UK’s National Cancer Research Institute on a large randomised clinical trial in front-line adult AML.