Copenhagen, Denmark; December 11, 2006 – Genmab A/S (CSE: GEN) announced today it has initiated a Phase II study of HuMax-CD20™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.  A total of 56 patients will be enrolled in the study.

 

“Disease progression in patients with advanced CLL is usually rapid and we hope using HuMax-CD20 in combination with FC as first line therapy will result in significant disease improvement for these patients,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. 

 

About the trial

Patients in this open label study will be randomized into two treatment groups of 28 patients each.  Each patient will receive 6 monthly infusions of either 500 or 1000 mg of HuMax-CD20 in combination with FC.  Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 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 6 month intervals until 48 months.

 

The objective in the study is to determine the efficacy of HuMax-CD20 in combination with FC in previously untreated CLL patients.  The primary endpoint is complete remission measured at any time during the treatment period.