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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 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

Rok publikování 2016
Druh Článek v odborném periodiku
Časopis / Zdroj Lancet Oncology
Fakulta / Pracoviště MU

Lékařská fakulta

Citace
Doi http://dx.doi.org/10.1016/S1470-2045(15)00465-9
Obor Onkologie a hematologie
Klíčová slova BRUTON TYROSINE KINASE; MANTLE CELL LYMPHOMA; INHIBITOR IBRUTINIB; PCI-32765; BTK; CYCLOPHOSPHAMIDE; FLUDARABINE; MALIGNANCY; DISEASE; TRIAL
Popis 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.

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