Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study

Chanan-Khan, Asher; Cramer, Paula; Demirkan, Fatih; Fraser, Graeme; Silva, Rodrigo; Grosicki, Sebastian; Pristupa, Aleksander; Janssens, Ann; Mayer, Jiri; Bartlett, Nancy; Dilhuydy, Marie-Sarah; Pylypenko, Halyna; Loscertales, Javier; Avigdor, Abraham; Rule, Simon; Villa, Diego; Samoilova, Olga; Panagiotidis, Panagiots; Goy, Andre; Mato, Anthony; Pavlovsky, Miguel; Karlsson, Claes; Mahler, Michelle; Salman, Mariya; Sun, Steven; Phelps, Charles; Balasubramanian, Sriram; Howes, Angela; Hallek, Michael; Assouline, S.; Bence-Bruckler, I.; Buckstein, R.; Fraser, G.; Larratt, L.; Minuk, L.; Villa, D.; Angevine, A.; Bartlett, N.; Bixby, D.; Caimi, P.; Chanan-Khan, A.; Craig, M.; Forero-Torres, A.; Ganguly, S.; Goy, A.; Heffner, L.; Hermann, R.; Lansigan, F.; Leis, J.; Letzer, J.; Link, B.; Liu, D.; McCaul, K.; McGuire, E.; Skinner, W.; Starodub, A.; Stuart, R.; Thirman, M.; Tirumali, N.; Yang, J.; Janssens, A.; Offner, F.; Van den Neste, E.; Van Hoof, A.; Mayer, J.; Novak, J.; Trneny, M.; Cartron, G.; Dartigeas, C.; Dilhuydy, M.; Ghez, D.; Haioun, C.; Leblond, V.; Salles, G.; Balser, C.; Cramer, P.; Dreger, P.; Durig, J.; Eckart, M.; Heinrich, B.; Illmer, T.; Jentsch-Ullrich, K.; Pfreundschuh, M.; Schetelig, J.; Schlag, R.; Soling, U.; Stilgenbaue, S.; Anagnostopoulos, A.; Dimopoulos, A.; Panagiotidis, P.; Vrakidou, E.; Bairey, O.; Ben Yehuda, D.; Braester, A.; Fineman, R.; Herishanu, Y.; Nagler, A.; Ruchlemer, R.; Tadmor, T.; Grosicki, S.; Homenda, W.; Jurczak, W.; Pluta, A.; Woszczyk, D.; Espirito Santo, A.; Luis, R.; Raposo, J.; Viveiros, C.; Alexeeva, J.; Dunaev, Y.; Golubeva, M.; Khuageva, N.; Loginov, A.; Lysenko, I.; Osmanov, E.; Pavlov, V.; Pristupa, A.; Proydakov, A.; Rossiev, V.; Samarina, I.; Samoilova, O.; Serduk, O.; Shneider, T.; Udovitsa, D.; Voloshin, S.; Gayoso, J.; Gonzalez, M.; Gonzalez Barca, E.; Hernandez Rivas, J.; Jargue, I.; Loscertales, J.; Karlsson, C.; Sender, M.; Aktan, M.; Arslan, O.; Demirkan, F.; Ferhanoglu, B.; Kaynar, L.; Sayinalp, NİLGÜN; Vaural, F.; Yagci, M.; Dyagil, I.; Kaplan, P.; Masliak, Z.; Oliynyk, H.; Popovska, T.; Pylypenko, H.; Rekhtman, G.; Dearden, C.; Morley, N.; Moss, P.; Rule, S.; Pavlovsky, M.; Riveros, D.; Santucci-Silva, R.; Romeo, M.; Scheliga, A.; Salazar, L.; Gomez, D.; Ramirez, E.; Jung, C.

doi:10.1016/s1470-2045(15)00465-9

Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study

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Chanan-Khan A., Cramer P., Demirkan F., Fraser G., Silva R. S., Grosicki S., ...More

LANCET ONCOLOGY, vol.17, no.2, pp.200-211, 2016 (SCI-Expanded)

Publication Type: Article / Article
Volume: 17 Issue: 2
Publication Date: 2016
Doi Number: 10.1016/s1470-2045(15)00465-9
Journal Name: LANCET ONCOLOGY
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Page Numbers: pp.200-211
Hacettepe University Affiliated: Yes

Abstract

Background Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma.