Patients in this open label study will be randomized into two dose groups of 28 patients each and will receive a total of six infusions of ofatumumab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP).
Each patient will receive 300mg of ofatumumab at the first infusion, followed by five subsequent infusions of either 500 or 1000mg of ofatumumab every three weeks, in combination with six cycles of CHOP. Disease status will be assessed at three months following the last treatment and then every three months until month 24, and every six months thereafter until 60 months or initiation of alternative treatment.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular non-Hodgkin’s lymphoma (NHL) patients. The primary endpoint in the study is objective response from start of treatment until three months after last administration of ofatumumab assessed according to the standardized response criteria for NHL.
Lisa Drakeman, CEO of Genmab, said: “We are happy to finish enrolment in this first study with ofatumumab in front line follicular NHL patients. We look forward to seeing the results of this trial.”