A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Summary Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and...

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Bibliographic Details
Published in:	British journal of haematology Vol. 167; no. 4; pp. 466 - 477
Main Authors:	Awan, Farrukh T., Hillmen, Peter, Hellmann, Andrzej, Robak, Tadeusz, Hughes, Steven G., Trone, Denise, Shannon, Megan, Flinn, Ian W., Byrd, John C.
Format:	Journal Article
Language:	English
Published:	Oxford Blackwell 01-11-2014
Subjects:	Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Murine-Derived - administration & dosage Antibodies, Monoclonal, Murine-Derived - adverse effects Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biological and medical sciences CD23 chronic lymphocytic leukaemia Cyclophosphamide - administration & dosage Cyclophosphamide - adverse effects Female Hematologic and hematopoietic diseases Humans Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis lumiliximab Male Medical sciences Middle Aged Recurrence Rituximab small lymphocytic lymphoma Tumors Vidarabine - administration & dosage Vidarabine - adverse effects Vidarabine - analogs & derivatives Antineoplastic agent Phase III trial Relapse small lymphocytic lymphoma FcεRII receptor Nucleotide analog Monoclonal antibody Randomization Cancerology Lymphoproliferative syndrome Immunotherapy Phase II trial Human Purine nucleotide Drug combination Hematology Treatment efficiency Rituximab Malignant hemopathy Lymphocytic lymphoma Alkylating agent Oxazaphosphinane derivatives Cyclophosphamide Chronic lymphocytic leukemia Fludarabine Treatment chronic lymphocytic leukaemia Antimetabolic Lumiliximab Nitrogen mustard Fluorine Organic compounds CD23 Comparative study Cancer lumiliximab
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Summary:	Summary Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open‐label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty‐seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression‐free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.
ISSN:	0007-1048 1365-2141
DOI:	10.1111/bjh.13061