The lintuzumab Phase IIb clinical trial is a randomized, double-blind, placebo-controlled study evaluating whether the combination regimen of lintuzumab and low-dose cytarabine chemotherapy extends overall survival compared to low-dose cytarabine alone in previously untreated acute myeloid leukemia (AML) patients age 60 and older who decline intensive chemotherapy.
The primary endpoint of the study, which is being conducted at more than 80 clinical sites worldwide, is overall survival.
In addition to the Phase IIb clinical trial, Seattle Genetics expects to present data from both the Phase I single-agent trial of lintuzumab in AML and myelodysplastic syndromes (MDS) the Phase I trial of lintuzumab in combination with Revlimid in advanced MDS during 2009.
Thomas Reynolds, chief medical officer of Seattle Genetics, said: “We are pleased to have achieved our enrollment goal of 210 patients in this global Phase IIb trial in less than 18 months. We anticipate that data from the trial, which is event-driven, will be available in the first half of 2010.”