Genmab: Recruitment Completed in Arzerra (Ofatumumab) Phase II Study in Relapsed DLBCL
Genmab A/S announced it has completed recruitment of 75 patients in the Phase II study of Arzerra(TM) (ofatumumab) to evaluate treatment of relapsed diffuse large B-cell lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant.
In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of up to 24 months after treatment start. After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60.
The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.
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