A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma

作者：Coiffier Bertrand^*; Radford John; Bosly Andre; Martinelli Giovanni; Barca Gabriela; Davies Andrew; Decaudin Didier; Gallop Evans Eve; Padmanabhan Iyer Swaminathan; Van Eygen Koen; Wu Ka Lung; Gupta Ira V; Lin Thomas S; Goldstein Nancy; Jewell Roxanne C; Winter Paul; Li**y Steen

来源：British Journal of Haematology, 2013, 163(3): 334-342.

DOI：10.1111/bjh.12537

• haematological malignancies
• immunotherapy
• lymphoid malignancies
• non-Hodgkin lymphoma
• diffuse large B-cell lymphoma

This international, multicentre phase II study was conducted to assess ofatumumab, a human anti-CD20 monoclonal antibody, in patients with relapsed/progressive diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation (TI) or who had relapse/progression after transplantation (PT). Eighty-one patients received ofatumumab 300mg intravenously (IV) on Day 1, followed by seven weekly IV infusions of 1000mg. Patients in the TI and PT groups had received a median of 3 (range, 1-7) and 5 (range, 2-7) prior therapies, respectively. One-third of patients did not respond to the last prior therapy, and 53% had failed two or more rituximab-containing therapies. Overall response rate was 13% for the TI group (seven partial responses) and 8% for the PT group (two complete responses). Median progression-free survival was 2 center dot 6 months, and median duration of response was 9 center dot 5 months. The most common Grade 3-4 adverse events were neutropenia (11%), leucopenia (6%), lymphopenia (6%) and thrombocytopenia (6%). Sixteen deaths have been reported, with disease progression as the most common cause of death. In conclusion, ofatumumab monotherapy was well tolerated and provided clinical benefit to some DLBCL patients in this study. This trial was registered at www.clinicaltrials.gov (NCT00622388).

• 出版日期2013-11