BASEL, SwitzerlandIn a pivotal phase III study, rituximab (Rituxan) in combination with standard chemotherapy significantly increased time to progression in patients with previously untreated chronic lymphocytic leukemia, compared with chemotherapy alone.
In a press release, Roche, which markets the agent in Europe as MabThera, announced that the CLL8 trial, initiated by the German CLL study group, had reached its primary endpoint almost a year ahead of schedule.
The randomized international trial was conducted at 203 sites across 11 countries. It included 817 patients with CLL receiving first-line treatmenteither rituximab with fludarabine and cyclophosphamide or chemotherapy alone. The study aimed to show a 35% increase in progression-free survival with rituximab.
Data from the CLL8 study will be submitted for presentation at upcoming international scientific meetings, the company said.