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

J 2016

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; Paula CRAMER; Fatih DEMIRKAN; Graeme FRASER; Rodrigo Santucci SILVA et. al.

Basic information

Original name

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

Authors

CHANAN-KHAN, Asher (840 United States of America); Paula CRAMER (276 Germany); Fatih DEMIRKAN (792 Turkey); Graeme FRASER (124 Canada); Rodrigo Santucci SILVA (76 Brazil); Sebastian GROSICKI (616 Poland); Aleksander PRISTUPA (643 Russian Federation); Ann JANSSENS (56 Belgium); Jiří MAYER (203 Czech Republic, guarantor, belonging to the institution); Nancy L BARTLETT (840 United States of America); Marie-Sarah DILHUYDY (250 France); Halyna PYLYPENKO (804 Ukraine); Javier LOSCERTALES (724 Spain); Abraham AVIGDOR (376 Israel); Simon RULE (826 United Kingdom of Great Britain and Northern Ireland); Diego VILLA (124 Canada); Olga SAMOILOVA (643 Russian Federation); Panagiots PANAGIOTIDIS (300 Greece); Andre GOY (840 United States of America); Anthony MATO (840 United States of America); Miguel A PAVLOVSKY (32 Argentina); Claes KARLSSON (752 Sweden); Michelle MAHLER (840 United States of America); Mariya SALMAN (840 United States of America); Steven SUN (840 United States of America); Charles PHELPS (840 United States of America); Sriram BALASUBRAMANIAN (840 United States of America); Angela HOWES (826 United Kingdom of Great Britain and Northern Ireland) and Michael HALLEK (276 Germany)

Edition

Lancet Oncology, New York, Elsevier Science INC, 2016, 1470-2045

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30200 3.2 Clinical medicine

Country of publisher

United States of America

Confidentiality degree

is not subject to a state or trade secret

Impact factor

Impact factor: 33.900

RIV identification code

RIV/00216224:14110/16:00089234

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/S1470-2045(15)00465-9

UT WoS

000369613900049

EID Scopus

2-s2.0-84959366494

Keywords in English

BRUTON TYROSINE KINASE; MANTLE CELL LYMPHOMA; INHIBITOR IBRUTINIB; PCI-32765; BTK; CYCLOPHOSPHAMIDE; FLUDARABINE; MALIGNANCY; DISEASE; TRIAL

Abstract

In the original language

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. Interpretation In patients eligible for bendamustine plus rituximab, the addition of ibrutinib to this regimen results in significant improvements in outcome with no new safety signals identified from the combination and a manageable safety profile.

Cite

CHANAN-KHAN, Asher; Paula CRAMER; Fatih DEMIRKAN; Graeme FRASER; Rodrigo Santucci SILVA; Sebastian GROSICKI; Aleksander PRISTUPA; Ann JANSSENS; Jiří MAYER; Nancy L BARTLETT; Marie-Sarah DILHUYDY; Halyna PYLYPENKO; Javier LOSCERTALES; Abraham AVIGDOR; Simon RULE; Diego VILLA; Olga SAMOILOVA; Panagiots PANAGIOTIDIS; Andre GOY; Anthony MATO; Miguel A PAVLOVSKY; Claes KARLSSON; Michelle MAHLER; Mariya SALMAN; Steven SUN; Charles PHELPS; Sriram BALASUBRAMANIAN; Angela HOWES and Michael HALLEK. 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. Lancet Oncology. New York: Elsevier Science INC, 2016, vol. 17, No 2, p. 200-211. ISSN 1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(15)00465-9.

@article{1322545,
   author = {ChananandKhan, Asher and Cramer, Paula and Demirkan, Fatih and Fraser, Graeme and Silva, Rodrigo Santucci and Grosicki, Sebastian and Pristupa, Aleksander and Janssens, Ann and Mayer, Jiří and Bartlett, Nancy L and Dilhuydy, MarieandSarah and Pylypenko, Halyna and Loscertales, Javier and Avigdor, Abraham and Rule, Simon and Villa, Diego and Samoilova, Olga and Panagiotidis, Panagiots and Goy, Andre and Mato, Anthony and Pavlovsky, Miguel A and Karlsson, Claes and Mahler, Michelle and Salman, Mariya and Sun, Steven and Phelps, Charles and Balasubramanian, Sriram and Howes, Angela and Hallek, Michael},
   article_location = {New York},
   article_number = {2},
   doi = {http://dx.doi.org/10.1016/S1470-2045(15)00465-9},
   keywords = {BRUTON TYROSINE KINASE; MANTLE CELL LYMPHOMA; INHIBITOR IBRUTINIB; PCI-32765; BTK; CYCLOPHOSPHAMIDE; FLUDARABINE; MALIGNANCY; DISEASE; TRIAL},
   language = {eng},
   issn = {1470-2045},
   journal = {Lancet Oncology},
   title = {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},
   volume = {17},
   year = {2016}
}

TY  - JOUR
ID  - 1322545
AU  - Chanan-Khan, Asher - Cramer, Paula - Demirkan, Fatih - Fraser, Graeme - Silva, Rodrigo Santucci - Grosicki, Sebastian - Pristupa, Aleksander - Janssens, Ann - Mayer, Jiří - Bartlett, Nancy L - Dilhuydy, Marie-Sarah - Pylypenko, Halyna - Loscertales, Javier - Avigdor, Abraham - Rule, Simon - Villa, Diego - Samoilova, Olga - Panagiotidis, Panagiots - Goy, Andre - Mato, Anthony - Pavlovsky, Miguel A - Karlsson, Claes - Mahler, Michelle - Salman, Mariya - Sun, Steven - Phelps, Charles - Balasubramanian, Sriram - Howes, Angela - Hallek, Michael
PY  - 2016
TI  - 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
JF  - Lancet Oncology
VL  - 17
IS  - 2
SP  - 200-211
EP  - 200-211
PB  - Elsevier Science INC
SN  - 14702045
KW  - BRUTON TYROSINE KINASE
KW  - MANTLE CELL LYMPHOMA
KW  - INHIBITOR IBRUTINIB
KW  - PCI-32765
KW  - BTK
KW  - CYCLOPHOSPHAMIDE
KW  - FLUDARABINE
KW  - MALIGNANCY
KW  - DISEASE
KW  - TRIAL
N2  - 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. Interpretation In patients eligible for bendamustine plus rituximab, the addition of ibrutinib to this regimen results in significant improvements in outcome with no new safety signals identified from the combination and a manageable safety profile.
ER  -

CHANAN-KHAN, Asher; Paula CRAMER; Fatih DEMIRKAN; Graeme FRASER; Rodrigo Santucci SILVA; Sebastian GROSICKI; Aleksander PRISTUPA; Ann JANSSENS; Jiří MAYER; Nancy L BARTLETT; Marie-Sarah DILHUYDY; Halyna PYLYPENKO; Javier LOSCERTALES; Abraham AVIGDOR; Simon RULE; Diego VILLA; Olga SAMOILOVA; Panagiots PANAGIOTIDIS; Andre GOY; Anthony MATO; Miguel A PAVLOVSKY; Claes KARLSSON; Michelle MAHLER; Mariya SALMAN; Steven SUN; Charles PHELPS; Sriram BALASUBRAMANIAN; Angela HOWES and Michael HALLEK. 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. \textit{Lancet Oncology}. New York: Elsevier Science INC, 2016, vol.~17, No~2, p.~200-211. ISSN~1470-2045. Available from: https://dx.doi.org/10.1016/S1470-2045(15)00465-9.

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