Genmab, headquartered in Denmark, has launched a late-stage pivotal study with HuMax-CD20 (ofatumumab) to treat patients with refractory B-cell chronic lymphocytic leukemia (CLL). HuMax-CD20 received a fast track designation from the U.S. FDA in December 2004 for this indication.
The study will include approximately 100 CLL patients who have failed treatment with fludarabine and alemtuzumab or who have failed fludarabine and are intolerant to or ineligible for alemtuzumab.
The objective of the study is to evaluate the efficacy and safety of HuMax-CD20, and the primary endpoint is objective response over a 24-weeks period from start of treatment.
