Genmab announced it has initiated a study of HuMax-CD20 to treat follicular non-Hodgkin's lymphoma (NHL) patients who are refractory to rituximab.
The study will include approximately 162 NHL patients who are refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment.
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1,000 mg of HuMax-CD20. Disease status will be assessed every three months until month 24.
The objective of the study is to determine the efficacy and safety of two dose regimens of HuMax-CD20. The primary endpoint of the study is objective response as measured over a six-month period from start of treatment assessed by an independent endpoints review committee according to the standardized response criteria for non-Hodgkin's lymphomas.