Genmab seeks to amend ofatumumab trial protocol

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Pharmaceutical company Genmab has announced that they are seeking a protocol amendment to the Phase III head-to-head study in diffuse large B-cell lymphoma (DLBCL).

The study pits Genmab's ofatumumab plus chemotherapy against rituximab plus chemotherapy and includes 410 patients with relapsed or refractory DLBCL following frontline therapy with rituximab and combination chemotherapy.

Patients will now receive the same combination chemotherapy regimen, DHAP, along with the antibody. They will receive three cycles of chemotherapy, and patients who achieve complete or partial responses will undergo high-dose chemotherapy followed by an autologous stem cell transplantation.

The study's primary endpoint is progression-free survival.

Source: Therapeutics Daily

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