Genmab Initiates HuMax-CD20 CLL Pivotal Study

Genmab has initiated a Phase III study with HuMax-CD20 to treat patients with refractory B-cell Chronic Lymphocytic Leukemia (CLL). HuMax-CD20 received a Fast Track designation from the 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. Patients in the single arm trial will receive eight weekly infusions of HuMax-CD20, followed by four monthly infusions. Patients will receive 300 mg of HuMax-CD20 at the first infusion and 2,000 mg of HuMax-CD20 at each subsequent infusion. Disease status will be assessed every four weeks until week 28 and then every three months until disease progression or month 24. The study will evaluate the efficacy and safety of HuMax-CD20 and the primary endpoint is objective response over a 24 weeks period from start of treatment.