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, Petach Tikva, 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

Research output: Contribution to journalArticle

19 Citations (Scopus)

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

Fingerprint

B-Cell Chronic Lymphocytic Leukemia
Cyclophosphamide
Safety
lumiliximab
fludarabine
Rituximab
Multicenter Studies
Disease-Free Survival
Monoclonal Antibodies
Incidence

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

Cite this

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

In: British Journal of Haematology, Vol. 167, No. 4, 01.11.2014, p. 466-477.

Research output: Contribution to journalArticle

Awan, FT, Hillmen, P, Hellmann, A, Robak, T, Hughes, SG, Trone, D, Shannon, M, Flinn, IW, Byrd, JC, Riveros, D, Pavlovsky, S, Iastrebner, CM, Carney, DA, Deveridge, S, Durrant, S, Hahn, UH, Hertzberg, M, Leahy, MF, Ma, D, Marlton, P, Mulligan, S, Opat, SS, Tiley, C, Wickham, NW, Cannell, P, Gatalano, J, Catalano, J, Cull, G, To, LB, Hopfinger, G, Jager, U, Linkesch, W, Petzer, A, Schwarzmeier, J, Steurer, M, Greil, R, Bememan, Z, Bosly, A, Bron, D, Janssens, A, Offner, F, Van Den Neste, EW, Wu, KL, Van Hoof, A, Maiolino, A, Pinczowski, H, Zanichelli, MA, Pereira, J, Larratt, L, Spaner, D, Howson-Jan, K, Chen, CI, Cantin, G, Fernandez, LA, Fraser, G, Mayer, J, Trneny, M, Jebavy, L, Bordessoule, D, Lamy, T, Milpied, N, Truchan-Graczyk, M, Eghbali, H, Karsenti, JM, Celigny, PS, Mans, L, Cazin, B, Gyan, E, Lepretre, S, Bergmann, L, Tsionos, K, Lokeshwar, NM, Agarwal, MB, Ross, CR, Deshmukh, CD, Narayanan, G, Raina, V, Bondarde, SA, Shah, BA, Bairey, O, Tikva, P, Shvidel, L, Ambrosetti, A, Rossi, PGB, Angelucci, E, Carella, AM, Massaia, M, Zinzani, PL, Caligaris-Cappio, F, Foa, R, Gaidano, G, della Caritá, AOM, Leone, G, Santoro, A, Griskevicius, L, Jurgutis, R, Baker, BW, Hawkins, T, Corbett, GM, Ganly, P, D'Souza, AB, Deptala, A, Holowiecki, J, Kloczko, J, Skotnicki, A, Zdziarska, B, Kyrcz-Krzemien, S, Dmoszynska, A, Moreira, A, Pereira, AP, Colita, A, Moicean, AD, Vasilica, M, Danaila, C, Gheorghita, E, Pavlov, VV, Rossiev, VA, Konstantinova, T, Samoilova, OS, Novgorod, N, Shelekhova, T, Zaritsky, AY, Abdulkadyrov, KM, Zyuzgin, IS, Pristupa, AS, Loscertales, J, Vidal, JB, de Mallorca, P, Gonzalez, M, Ortuno, F, Giraldo, P, Nathwani, A, Agrawal, SG, Rule, S, Dearden, CE, Bloor, AJ, Haynes, A, Singer, C, Boclek, RG, Bosserman, LD, Chan, D, Davidson, SJ, Dichmann, RA, Farber, C, Hart, L, Hermann, R, Hu, E, Janakiraman, N, Jonas, W, Liem, KD, Mcintyre, RE, O'Brien, S, Patel, G, Rado, T, Schilder, R, Smith, SE, Stock, W, Turturro, F, Venugopal, P, Anderson, TC, Berry, W, Boyd, TE, Byrd, J, Cooper, M, Flinn, I, Gersh, R, Gordon, D, Guzley, GJ, Wilks, ST, Klein, A, Krauss, JC, Lister, J, Mandell, L, Molina, A, Cooper, B, Pendergrass, KB, Reeder, C, Savin, MA, Spitzer, G, Tuscano, JM, vanDeventer, H, Eradat, HA, Masood, A & Mena, R 2014, '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', British Journal of Haematology, vol. 167, no. 4, pp. 466-477. https://doi.org/10.1111/bjh.13061
Awan, Farrukh T. ; Hillmen, Peter ; Hellmann, Andrzej ; Robak, Tadeusz ; Hughes, Steven G. ; Trone, Denise ; Shannon, Megan ; Flinn, Ian W. ; Byrd, John C. ; Riveros, Dardo ; Pavlovsky, Santiago ; Iastrebner, Claudio M. ; Carney, Dennis A. ; Deveridge, Sandra ; Durrant, Simon ; Hahn, Uwe H. ; Hertzberg, Mark ; Leahy, Michael F. ; Ma, David ; Marlton, Paula ; Mulligan, Stephen ; Opat, Stephen S. ; Tiley, Campbell ; Wickham, Nicholas W. ; Cannell, Paul ; Gatalano, John ; Catalano, John ; Cull, Gavin ; To, Luen B. ; Hopfinger, Georg ; Jager, Ulrich ; Linkesch, Werner ; Petzer, Andreas ; Schwarzmeier, Josef ; Steurer, Michael ; Greil, Richard ; Bememan, Zwi ; Bosly, Andre ; Bron, Dominique ; Janssens, Ann ; Offner, Fritz ; Van Den Neste, Eric W. ; Wu, Ka Lung ; Van Hoof, Achiel ; Maiolino, Angelo ; Pinczowski, Helio ; Zanichelli, Maria A. ; Pereira, Juliana ; Larratt, Loree ; Spaner, David ; Howson-Jan, Kang ; Chen, Christine I. ; Cantin, Guy ; Fernandez, Louis A. ; Fraser, Graeme ; Mayer, Jiri ; Trneny, Marek ; Jebavy, Ladislav ; Bordessoule, Dominique ; Lamy, Thierry ; Milpied, Noel ; Truchan-Graczyk, Malgorzata ; Eghbali, Houchingue ; Karsenti, Jean Michel ; Celigny, Philippe Solal ; Mans, Le ; Cazin, Bruno ; Gyan, Emmanuel ; Lepretre, Stephane ; Bergmann, Lothar ; Tsionos, Konstantinos ; Lokeshwar, Nilesh M. ; Agarwal, Mohan B. ; Ross, Cecil R. ; Deshmukh, Chetan D. ; Narayanan, Geetha ; Raina, Vinod ; Bondarde, Shailesh A. ; Shah, Bhavin A. ; Bairey, Osnat ; Tikva, Petach ; Shvidel, Lev ; Ambrosetti, Achille ; Rossi, Policlinico G B ; Angelucci, Emanuele ; Carella, Angelo M. ; Massaia, Massimo ; Zinzani, Pier L. ; Caligaris-Cappio, Federico ; Foa, Roberto ; Gaidano, Gianluca ; della Caritá, A. O Maggiore ; Leone, Giuseppe ; Santoro, Armando ; Griskevicius, Laimonas ; Jurgutis, Romualdas ; Baker, Bartrum W. ; Hawkins, Timothy ; Corbett, Gillian M. ; Ganly, Peter ; D'Souza, Alvyn B. ; Deptala, Andrzej ; Holowiecki, Jerzy ; Kloczko, Janusz ; Skotnicki, Aleksander ; Zdziarska, Barbara ; Kyrcz-Krzemien, Slawomira ; Dmoszynska, Anna ; Moreira, Anna ; Pereira, Ana P. ; Colita, Andrei ; Moicean, Andreea D. ; Vasilica, Mariana ; Danaila, Catalin ; Gheorghita, Emanuil ; Pavlov, Vyacheslav V. ; Rossiev, Viktor A. ; Konstantinova, Tatiana ; Samoilova, Olga S. ; Novgorod, Nizhniy ; Shelekhova, Tatyana ; Zaritsky, Andrey Y. ; Abdulkadyrov, Kudrat M. ; Zyuzgin, Ilya S. ; Pristupa, Alexander S. ; Loscertales, Javier ; Vidal, Joan Besalduch ; de Mallorca, Palma ; Gonzalez, Marcos ; Ortuno, Francisco ; Giraldo, Pilar ; Nathwani, Amit ; Agrawal, Samir G. ; Rule, Simon ; Dearden, Claire E. ; Bloor, Adrian J. ; Haynes, Andrew ; Singer, Charles ; Boclek, Robert G. ; Bosserman, Linda D. ; Chan, David ; Davidson, Sheldon J. ; Dichmann, Robert A. ; Farber, Charles ; Hart, Lowell ; Hermann, Robert ; Hu, Eddie ; Janakiraman, Nalini ; Jonas, William ; Liem, Kiem D. ; Mcintyre, Rosemary E. ; O'Brien, Susan ; Patel, Giribala ; Rado, Thomas ; Schilder, Russell ; Smith, Scott E. ; Stock, Wendy ; Turturro, Francesco ; Venugopal, Parameswaran ; Anderson, Thomas C. ; Berry, William ; Boyd, Thomas E. ; Byrd, John ; Cooper, Maureen ; Flinn, Ian ; Gersh, Robert ; Gordon, David ; Guzley, Gregory J. ; Wilks, Sharon T. ; Klein, Andreas ; Krauss, John C. ; Lister, John ; Mandell, Lance ; Molina, Arthur ; Cooper, Barry ; Pendergrass, Kelly B. ; Reeder, Craig ; Savin, Michael A. ; Spitzer, Gary ; Tuscano, Joseph M. ; vanDeventer, Hendrik ; Eradat, Herbert A. ; Masood, Aisha ; Mena, Raul. / 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. In: British Journal of Haematology. 2014 ; Vol. 167, No. 4. pp. 466-477.
@article{df83d2a25b894961b0f6f8aac5c842c8,
title = "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",
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.",
keywords = "CD23, Chronic lymphocytic leukaemia, Lumiliximab, Small lymphocytic lymphoma",
author = "Awan, {Farrukh T.} and Peter Hillmen and Andrzej Hellmann and Tadeusz Robak and Hughes, {Steven G.} and Denise Trone and Megan Shannon and Flinn, {Ian W.} and Byrd, {John C.} and Dardo Riveros and Santiago Pavlovsky and Iastrebner, {Claudio M.} and Carney, {Dennis A.} and Sandra Deveridge and Simon Durrant and Hahn, {Uwe H.} and Mark Hertzberg and Leahy, {Michael F.} and David Ma and Paula Marlton and Stephen Mulligan and Opat, {Stephen S.} and Campbell Tiley and Wickham, {Nicholas W.} and Paul Cannell and John Gatalano and John Catalano and Gavin Cull and To, {Luen B.} and Georg Hopfinger and Ulrich Jager and Werner Linkesch and Andreas Petzer and Josef Schwarzmeier and Michael Steurer and Richard Greil and Zwi Bememan and Andre Bosly and Dominique Bron and Ann Janssens and Fritz Offner and {Van Den Neste}, {Eric W.} and Wu, {Ka Lung} and {Van Hoof}, Achiel and Angelo Maiolino and Helio Pinczowski and Zanichelli, {Maria A.} and Juliana Pereira and Loree Larratt and David Spaner and Kang Howson-Jan and Chen, {Christine I.} and Guy Cantin and Fernandez, {Louis A.} and Graeme Fraser and Jiri Mayer and Marek Trneny and Ladislav Jebavy and Dominique Bordessoule and Thierry Lamy and Noel Milpied and Malgorzata Truchan-Graczyk and Houchingue Eghbali and Karsenti, {Jean Michel} and Celigny, {Philippe Solal} and Le Mans and Bruno Cazin and Emmanuel Gyan and Stephane Lepretre and Lothar Bergmann and Konstantinos Tsionos and Lokeshwar, {Nilesh M.} and Agarwal, {Mohan B.} and Ross, {Cecil R.} and Deshmukh, {Chetan D.} and Geetha Narayanan and Vinod Raina and Bondarde, {Shailesh A.} and Shah, {Bhavin A.} and Osnat Bairey and Petach Tikva and Lev Shvidel and Achille Ambrosetti and Rossi, {Policlinico G B} and Emanuele Angelucci and Carella, {Angelo M.} and Massimo Massaia and Zinzani, {Pier L.} and Federico Caligaris-Cappio and Roberto Foa and Gianluca Gaidano and {della Carit{\'a}}, {A. O Maggiore} and Giuseppe Leone and Armando Santoro and Laimonas Griskevicius and Romualdas Jurgutis and Baker, {Bartrum W.} and Timothy Hawkins and Corbett, {Gillian M.} and Peter Ganly and D'Souza, {Alvyn B.} and Andrzej Deptala and Jerzy Holowiecki and Janusz Kloczko and Aleksander Skotnicki and Barbara Zdziarska and Slawomira Kyrcz-Krzemien and Anna Dmoszynska and Anna Moreira and Pereira, {Ana P.} and Andrei Colita and Moicean, {Andreea D.} and Mariana Vasilica and Catalin Danaila and Emanuil Gheorghita and Pavlov, {Vyacheslav V.} and Rossiev, {Viktor A.} and Tatiana Konstantinova and Samoilova, {Olga S.} and Nizhniy Novgorod and Tatyana Shelekhova and Zaritsky, {Andrey Y.} and Abdulkadyrov, {Kudrat M.} and Zyuzgin, {Ilya S.} and Pristupa, {Alexander S.} and Javier Loscertales and Vidal, {Joan Besalduch} and {de Mallorca}, Palma and Marcos Gonzalez and Francisco Ortuno and Pilar Giraldo and Amit Nathwani and Agrawal, {Samir G.} and Simon Rule and Dearden, {Claire E.} and Bloor, {Adrian J.} and Andrew Haynes and Charles Singer and Boclek, {Robert G.} and Bosserman, {Linda D.} and David Chan and Davidson, {Sheldon J.} and Dichmann, {Robert A.} and Charles Farber and Lowell Hart and Robert Hermann and Eddie Hu and Nalini Janakiraman and William Jonas and Liem, {Kiem D.} and Mcintyre, {Rosemary E.} and Susan O'Brien and Giribala Patel and Thomas Rado and Russell Schilder and Smith, {Scott E.} and Wendy Stock and Francesco Turturro and Parameswaran Venugopal and Anderson, {Thomas C.} and William Berry and Boyd, {Thomas E.} and John Byrd and Maureen Cooper and Ian Flinn and Robert Gersh and David Gordon and Guzley, {Gregory J.} and Wilks, {Sharon T.} and Andreas Klein and Krauss, {John C.} and John Lister and Lance Mandell and Arthur Molina and Barry Cooper and Pendergrass, {Kelly B.} and Craig Reeder and Savin, {Michael A.} and Gary Spitzer and Tuscano, {Joseph M.} and Hendrik vanDeventer and Eradat, {Herbert A.} and Aisha Masood and Raul Mena",
year = "2014",
month = "11",
day = "1",
doi = "10.1111/bjh.13061",
language = "English (US)",
volume = "167",
pages = "466--477",
journal = "British Journal of Haematology",
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TY - JOUR

T1 - 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

AU - Awan, Farrukh T.

AU - Hillmen, Peter

AU - Hellmann, Andrzej

AU - Robak, Tadeusz

AU - Hughes, Steven G.

AU - Trone, Denise

AU - Shannon, Megan

AU - Flinn, Ian W.

AU - Byrd, John C.

AU - Riveros, Dardo

AU - Pavlovsky, Santiago

AU - Iastrebner, Claudio M.

AU - Carney, Dennis A.

AU - Deveridge, Sandra

AU - Durrant, Simon

AU - Hahn, Uwe H.

AU - Hertzberg, Mark

AU - Leahy, Michael F.

AU - Ma, David

AU - Marlton, Paula

AU - Mulligan, Stephen

AU - Opat, Stephen S.

AU - Tiley, Campbell

AU - Wickham, Nicholas W.

AU - Cannell, Paul

AU - Gatalano, John

AU - Catalano, John

AU - Cull, Gavin

AU - To, Luen B.

AU - Hopfinger, Georg

AU - Jager, Ulrich

AU - Linkesch, Werner

AU - Petzer, Andreas

AU - Schwarzmeier, Josef

AU - Steurer, Michael

AU - Greil, Richard

AU - Bememan, Zwi

AU - Bosly, Andre

AU - Bron, Dominique

AU - Janssens, Ann

AU - Offner, Fritz

AU - Van Den Neste, Eric W.

AU - Wu, Ka Lung

AU - Van Hoof, Achiel

AU - Maiolino, Angelo

AU - Pinczowski, Helio

AU - Zanichelli, Maria A.

AU - Pereira, Juliana

AU - Larratt, Loree

AU - Spaner, David

AU - Howson-Jan, Kang

AU - Chen, Christine I.

AU - Cantin, Guy

AU - Fernandez, Louis A.

AU - Fraser, Graeme

AU - Mayer, Jiri

AU - Trneny, Marek

AU - Jebavy, Ladislav

AU - Bordessoule, Dominique

AU - Lamy, Thierry

AU - Milpied, Noel

AU - Truchan-Graczyk, Malgorzata

AU - Eghbali, Houchingue

AU - Karsenti, Jean Michel

AU - Celigny, Philippe Solal

AU - Mans, Le

AU - Cazin, Bruno

AU - Gyan, Emmanuel

AU - Lepretre, Stephane

AU - Bergmann, Lothar

AU - Tsionos, Konstantinos

AU - Lokeshwar, Nilesh M.

AU - Agarwal, Mohan B.

AU - Ross, Cecil R.

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AU - vanDeventer, Hendrik

AU - Eradat, Herbert A.

AU - Masood, Aisha

AU - Mena, Raul

PY - 2014/11/1

Y1 - 2014/11/1

N2 - 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.

AB - 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.

KW - CD23

KW - Chronic lymphocytic leukaemia

KW - Lumiliximab

KW - Small lymphocytic lymphoma

UR - http://www.scopus.com/inward/record.url?scp=84911405920&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84911405920&partnerID=8YFLogxK

U2 - 10.1111/bjh.13061

DO - 10.1111/bjh.13061

M3 - Article

C2 - 25130401

AN - SCOPUS:84911405920

VL - 167

SP - 466

EP - 477

JO - British Journal of Haematology

JF - British Journal of Haematology

SN - 0007-1048

IS - 4

ER -