SCHERING, BIOGEN BEGIN TRIAL OF ZEVALIN IN AGGRESSIVE LYMPHOMA

Schering AG and Biogen Idec have announced the start of the Zevalin (ibritumomab tiuxetan) in aggressive lymphoma (ZEAL) trial, a Phase III, international multicenter clinical study. Approximately 400 patients will be enrolled in the trial.

This is an open-label, prospective, randomized, two-armed, group-sequential study evaluating the efficacy and safety of Zevalin treatment versus observation in patients with diffuse large-B-cell lymphoma (DLBCL) -- the most common type of aggressive non-Hodgkin's lymphoma (NHL) -- who are in complete remission (CR) or unconfirmed complete remission (CRu) after first-line CHOP-rituximab (CHOP-R) therapy. The trial is being conducted in 46 U.S. and 57 European, Asian and Canadian centers. The duration of treatment will consist of two treatment days one week apart followed by a 12-week safety follow-up period. The study will last approximately four years. Entry criteria include patients over 60 with DLBCL who are in CR or CRu after six or eight cycles of first-line treatment with CHOP-R.

The primary endpoint for the trial is overall survival (OS), with disease-free survival and health-related quality of life as secondary endpoints. Once the final data from the trial is completed and analyzed, the companies expect to file an application seeking to expand the product's current label to include first-line therapy for patients with aggressive DLBCL.