title: A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma.
abstract: 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.
authors.affiliation: Service d'Hematologie, Hospices Civils de Lyon, Lyon, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: André
authors.initials: A
authors.lastname: Bosly
authors.forename: Giovanni
authors.initials: G
authors.lastname: Martinelli
authors.forename: Gregor
authors.initials: G
authors.lastname: Verhoef
authors.forename: Gabriela
authors.initials: G
authors.lastname: Barca
authors.forename: Andrew
authors.initials: A
authors.lastname: Davies
authors.forename: Didier
authors.initials: D
authors.lastname: Decaudin
authors.forename: Eve
authors.initials: E
authors.lastname: Gallop-Evans
authors.forename: Swaminathan
authors.initials: S
authors.lastname: Padmanabhan-Iyer
authors.forename: Koen
authors.initials: K
authors.lastname: Van Eygen
authors.forename: Ka Lung
authors.initials: KL
authors.lastname: Wu
authors.forename: Ira V
authors.initials: IV
authors.lastname: Gupta
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Lin
authors.forename: Nancy
authors.initials: N
authors.lastname: Goldstein
authors.forename: Roxanne C
authors.initials: RC
authors.lastname: Jewell
authors.forename: Paul
authors.initials: P
authors.lastname: Winter
authors.forename: Steen
authors.initials: S
authors.lastname: Lisby
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000493:pharmacokinetics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D018951:Antigens, CD20 / Q000276:immunology; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D019008:Drug Resistance, Neoplasm; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D016403:Lymphoma, Large B-Cell, Diffuse / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D018951:Antigens, CD20; D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D000069283:Rituximab; C527517:ofatumumab
keywords: diffuse large B-cell lymphoma; haematological malignancies; immunotherapy; lymphoid malignancies; non-Hodgkin lymphoma