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

Farrukh T. Awan*, Peter Hillmen, Andrzej Hellmann, Tadeusz Robak, Steven G. Hughes, Denise Trone, Megan Shannon, Ian W. Flinn, John C. Byrd, Dardo Riveros, Santiago Pavlovsky, Claudio M. Iastrebner, Dennis A. Carney, Sandra Deveridge, Simon Durrant, Uwe H. Hahn, Mark Hertzberg, Michael F. Leahy, David Ma, Paula MarltonStephen Mulligan, Stephen S. Opat, Campbell Tiley, Nicholas W. Wickham, Paul Cannell, John Gatalano, John Catalano, Gavin Cull, Luen B. To, Georg Hopfinger, Ulrich Jager, Werner Linkesch, Andreas Petzer, Josef Schwarzmeier, Michael Steurer, Richard Greil, Zwi Bememan, Andre Bosly, Dominique Bron, Ann Janssens, Fritz Offner, Eric W. Van Den Neste, Ka Lung Wu, Achiel Van Hoof, Angelo Maiolino, Helio Pinczowski, Maria A. Zanichelli, Juliana Pereira, Loree Larratt, David Spaner, Kang Howson-Jan, Christine I. Chen, Guy Cantin, Louis A. Fernandez, Graeme Fraser, Jiri Mayer, Marek Trneny, Ladislav Jebavy, Dominique Bordessoule, Thierry Lamy, Noel Milpied, Malgorzata Truchan-Graczyk, Houchingue Eghbali, Jean Michel Karsenti, Philippe Solal Celigny, Le Mans, Bruno Cazin, Emmanuel Gyan, Stephane Lepretre, Lothar Bergmann, Konstantinos Tsionos, Nilesh M. Lokeshwar, Mohan B. Agarwal, Cecil R. Ross, Chetan D. Deshmukh, Geetha Narayanan, Vinod Raina, Shailesh A. Bondarde, Bhavin A. Shah, Osnat Bairey, Dina Ben Yehuda, Lev Shvidel, Achille Ambrosetti, Policlinico G.B. Rossi, Emanuele Angelucci, Angelo M. Carella, Massimo Massaia, Pier L. Zinzani, Federico Caligaris-Cappio, Roberto Foa, Gianluca Gaidano, A. O.Maggiore della Caritá, Giuseppe Leone, Armando Santoro, Laimonas Griskevicius, Romualdas Jurgutis, Bartrum W. Baker, Timothy Hawkins, Gillian M. Corbett, Peter Ganly, Alvyn B. D'Souza, Andrzej Deptala, Jerzy Holowiecki, Janusz Kloczko, Aleksander Skotnicki, Barbara Zdziarska, Slawomira Kyrcz-Krzemien, Anna Dmoszynska, Anna Moreira, Ana P. Pereira, Andrei Colita, Andreea D. Moicean, Mariana Vasilica, Catalin Danaila, Emanuil Gheorghita, Vyacheslav V. Pavlov, Viktor A. Rossiev, Tatiana Konstantinova, Olga S. Samoilova, Nizhniy Novgorod, Tatyana Shelekhova, Andrey Y. Zaritsky, Kudrat M. Abdulkadyrov, Ilya S. Zyuzgin, Alexander S. Pristupa, Javier Loscertales, Joan Besalduch Vidal, Palma de Mallorca, Marcos Gonzalez, Francisco Ortuno, Pilar Giraldo, Amit Nathwani, Samir G. Agrawal, Simon Rule, Claire E. Dearden, Adrian J. Bloor, Andrew Haynes, Charles Singer, Robert G. Boclek, Linda D. Bosserman, David Chan, Sheldon J. Davidson, Robert A. Dichmann, Charles Farber, Lowell Hart, Robert Hermann, Eddie Hu, Nalini Janakiraman, William Jonas, Kiem D. Liem, Rosemary E. Mcintyre, Susan O'Brien, Giribala Patel, Thomas Rado, Russell Schilder, Scott E. Smith, Wendy Stock, Francesco Turturro, Parameswaran Venugopal, Thomas C. Anderson, William Berry, Thomas E. Boyd, John Byrd, Maureen Cooper, Ian Flinn, Robert Gersh, David Gordon, Gregory J. Guzley, Sharon T. Wilks, Andreas Klein, John C. Krauss, John Lister, Lance Mandell, Arthur Molina, Barry Cooper, Kelly B. Pendergrass, Craig Reeder, Michael A. Savin, Gary Spitzer, Joseph M. Tuscano, Hendrik vanDeventer, Herbert A. Eradat, Aisha Masood, Raul Mena

*Corresponding author for this work

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Abstract

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.

Original languageEnglish
Pages (from-to)466-477
Number of pages12
JournalBritish Journal of Haematology
Volume167
Issue number4
DOIs
StatePublished - 1 Nov 2014
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2014 John Wiley & Sons Ltd.

Keywords

  • CD23
  • Chronic lymphocytic leukaemia
  • Lumiliximab
  • Small lymphocytic lymphoma

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