The study includes chronic lymphocytic leukemia (CLL) patients who are refractory to both fludarabine and alemtuzumab and patients who are refractory to fludarabine and who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes.
Each group will be analyzed separately and it is hoped that registration of ofatumumab may be possible in each indication, depending on the data generated from this study and the ongoing discussions with the regulatory authorities.
All patients in the study will receive eight weekly infusions of ofatumumab, followed by four monthly infusions of ofatumumab. Patients will receive 300mg of ofatumumab at the first infusion and 2,000mg of ofatumumab 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.
An interim analysis will be conducted on this cohort when 24-week efficacy data are available. The study will remain open for recruitment in order to collect additional safety and efficacy data.
Ofatumumab is an investigational, fully human, next-generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of b-cells. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.