BASEL, SwitzerlandIn a pivotal phase III study, rituximab(Drug information on 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(Drug information on 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.