A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma.
Authors
Coiffier, BRadford, John A
Bosly, A
Martinelli, G
Barca, G
Davies, A
Decaudin, D
Gallop-Evans, E
Padmanabhan-Iyer, S
Van Eygen, K
Wu, K
Gupta, I
Lin, T
Goldstein, N
Jewell, R
Winter, P
Lisby, S
Affiliation
Service d'Hematologie, Hospices Civils de Lyon, Lyon, France.Issue Date
2013-11
Metadata
Show full item recordAbstract
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 300 mg intravenously (IV) on Day 1, followed by seven weekly IV infusions of 1000 mg. 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 2·6 months, and median duration of response was 9·5 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.Citation
A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. 2013, 163 (3):334-42 Br J HaematolJournal
British Journal of HaematologyDOI
10.1111/bjh.12537PubMed ID
24032456Type
ArticleLanguage
enISSN
1365-2141ae974a485f413a2113503eed53cd6c53
10.1111/bjh.12537
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