Phase III CLL8 trial shows Rituxan plus FC chemotherapy improves patients with CLL

December 23, 2015

Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. The primary endpoint for CLL8 was PFS and secondary endpoints were overall survival (OS), event-free survival, duration of response, response rate, complete response and toxicity. CLL8 evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone and met the primary endpoint of improving PFS. The primary study analysis was reported at ASH 2008.

As previously reported, Grade 3 or greater adverse events occurred more frequently in the Rituxan plus FC arm, compared to the FC arm, in particular neutropenia, but this did not result in an increased infection rate. In CLL8, the most common adverse events that occurred more often in the Rituxan plus FC arm included blood and lymphatic system disorders, infections and neoplasms. Grade 3 or greater events that occurred more often in the Rituxan plus FC arm included hematologic toxicity (56 percent vs. 39 percent), neutropenia (34 percent vs. 21 percent) and leukocytopenia (24 percent vs. 12 percent).

CLL8 was one of two studies submitted for review by the U.S. Food and Drug Administration (FDA) in an application for a potential label for Rituxan plus FC in CLL. The companies are committed to making Rituxan plus FC an FDA-approved option for people with CLL.