Genmab completes enrollment of Phase II leukemia trial

Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive six monthly infusions of either 500 or 1000mg of ofatumumab in combination with fludarabine and cyclophosphamide (FC).

Disease status will be measured every four weeks until week 24 according to National Cancer Institute working group guidelines and every three months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months will be followed for disease progression at six month intervals until 48 months.

The objective of the study is to determine the efficacy of ofatumumab in combination with FC in previously untreated chronic lymphocytic leukemia (CLL) patients. The primary endpoint is complete remission measured at any time during the treatment period.