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; 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
• Year of publication: 2016
• Type: Article in Periodical
• Magazine / Source: Lancet Oncology
• MU Faculty or unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1016/S1470-2045(15)00465-9
• Field: Oncology and hematology
• Keywords: BRUTON TYROSINE KINASE; MANTLE CELL LYMPHOMA; INHIBITOR IBRUTINIB; PCI-32765; BTK; CYCLOPHOSPHAMIDE; FLUDARABINE; MALIGNANCY; DISEASE; TRIAL
• Description: 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.