US drug developer Seattle Genetics has completed patient enrollment in a Phase IIb trial of lintuzumab (SGN-33) in combination with low-dose cytarabine chemotherapy for patients with acute myeloid leukemia.
"We are pleased to have achieved our enrollment goal of 210 patients in this global Phase IIb trial in less than 18 months," said Thomas Reynolds, chief medical officer of the firm. "This trial is designed to determine if combining lintuzumab with a low-dose regimen of chemotherapy extends survival in older AML patients, a setting where there are limited treatment alternatives and patients have a median survival of less than six months. We anticipate that data from the trial, which is event-driven, will be available in the first half of 2010," he added.
The lintuzumab Phase IIb 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 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.
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