References
- Eichhorst BF, Busch R, Hopfinger G, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006;107:885–891.
- Flinn IW, Neuberg DS, Grever MR, et al. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007;25:793–798.
- Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376:1164–1174.
- Tam CS, O’Brien S, Wierda W, et al. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood. 2008;112:975–980.
- Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370:1101–1110.
- Laurenti L, Vannata B, Innocenti I, et al. Chlorambucil plus rituximab as front-line therapy in elderly/unfit patients affected by B-cell chronic lymphocytic leukemia: results of a single-centre experience. Mediterr J Hematol Infect Dis. 2013;5(1):e2013031.
- Hillmen P, Gribben JG, Follows GA, et al. Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: final analysis of an open-label phase II study. J Clin Oncol. 2014;32:1236–1241.
- Foà R, Del Giudice I, Cuneo A, et al. Chlorambucil plus rituximab with or without maintenance rituximab as first-line treatment for elderly chronic lymphocytic leukemia patients. Am J Hematol. 2014;89:480–486.
- Laurenti L, Innocenti I, Autore F. Chlorambucil plus rituximab as front-line therapy for elderly and/or unfit chronic lymphocytic leukemia patients: correlation with biologically-based risk stratification. Haematologica. 2017 Sep;102(9):e352–e355.
- Hillmen P, Robak T, Janssens A, et al. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015;385(9980):1873–1883.
- Laurenti L, Innocenti I, Autore F, et al. Bendamustine in combination with rituximab for elderly patients with previously untreated B-cell chronic lymphocytic leukemia: A retrospective analysis of real-life practice in Italian hematology departments. Leuk Res. 2015 Oct;39(10):1066–1070. Epub 2015 Jul 26. DOI:10.1016/j.leukres.2015.07.009
- Gentile M, Zirlik K, Ciolli S, et al. Combination of bendamustine and rituximab as front- line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials. Eur J Cancer. 2016 Jun;60:154–165.
- Michallet AS, Aktan M, Schuh A, et al. Rituximab in combination with bendamustine or chlorambucil for the treatment of chronic lymphocytic leukaemia: primary results from the randomized phase IIIb MABLE study. Abstract from the XVI International Workshop on Chronic Lymphocytic Leukemia 2015. Leukemia & Lymphoma.
- Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO clinical practice guidelines. Ann Oncol. 2015;26(suppl 5):78–84.
- Weiner GJ. Rituximab: mechanism of action. Semin Hematol. 2010;47(2):115–123.
- Robak T. Ofatumumab, a human monoclonal antibody for lymphoid malignancies and autoimmune disorders. Curr Opin Mol Ther. 2008;10:294–309.
- Teeling JL, French RR, Cragg MS, et al. Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood. 2004;104:1793–1800.
- Teeling JL, Mackus WJ, Wiegman LJ, et al. The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. J Immunol. 2006;177(1):362–371.
- Wierda WG, Padmanabhan S, Chan GW, et al. Ofatumumab is active in patients with fludarabine-refractory CLL irrespective of prior rituximab: results from the phase 2 international study. Blood. 2011;118:5126–5129.
- Shanafelt T, Lanasa M, Call T, et al. Ofatumumab-based chemoimmunotherapy is effective and well tolerated in patients with previously untreated chronic lymphocytic leukemia (CLL). Cancer. 2013;119:3788–3796.
- Byrd JC, Flynn JM, Kipps TJ, et al. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic. Blood. 2016;127(1):79–86.
- Teelling JL, French RR, Cragg MS, et al. Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood. 2004;104(6):1793–1800.
- Goede V, Fischer K, Engelke A, et al. Obinutuzumab as front line treatment of chronic lymphocytic leukemia: updated results of CLL11 study. Leukemia. 2015;29(7):1602–1604.
- Eichhorst B, Fink AM, Bahlo J, et al. First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016;17(7):928–942.
- Knauf WU, Lissitchkov T, Aldaoud A. Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial. Br J Haematol. 2012;159(1):67–77.
- Flinn IW, Panayiotidis P, Afanasyev B, et al. A phase 2, multicenter study investigating ofatumumab and bendamustine combination in patients with untreated or relapsed CLL. Am J Hematol. 2016 Sep;91(9):900–906.
- Wierda WG, Zelenetz AD, Gordon LI, et al. NCCN guidelines insights: chronic lymphocytic leukemia/small lymphocytic leukemia, version 1.2017. J Natl Compr Canc Netw. 2017 Mar;15(3):293–311.
- Honigberg LA, Smith AM, Sirisawad M, et al. The bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy. Proc Natl Acad Sci USA. 2010;107(29):13075–13080.
- Buggy JJ, Elias L. Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol. 2012;31(2):119–132.
- Baracho GV, Miletic AV, Omori SA, et al. Emergence of the PI3- kinase pathway as a central modulator of normal and aberrant B cell differentiation. Curr Opin Immunol. 2011;23(2):178–183.
- So L, Fruman DA. PI3K signalling in B- and T-lymphocytes: new developments and therapeutic advances. Biochem J. 2012;442(3):465–481.
- Wiestner A. Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. Blood. 2012;120(24):4684–4691.
- De Claro RA, McGinn KM, Verdun N, et al. FDA approval: ibrutinib for patients with previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia. Clin Cancer Res. 2015;21(16):3586–3590.
- Byrd JC, Furman RR, Coutre SE, et al. Three year follow-up of treatment- naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015;125(16):2497–2506.
- Farooqui MZ, Valdez J, Martyr S, et al. Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: a phase 2, single-arm trial. Lancet Oncol. 2015;16(2):169–176.
- Zydelig SmPC (Sep 2014; available at www.ema.europa.eu)
- Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014;370:997–1007.
- Jones JA, Robak T, Brown JR, et al. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017;4(3):e114–e126.
- O’Brien SM, Lamanna N, Kipps TJ, et al. A phase 2 study of idelalisib plus rituximab in treatment-naïve older patients with chronic lymphocytic leukemia. Blood. 2015;126(25):2686–2694.
- Hillmen PR, Badoux X, Delgado J, et al. Safety results of terminated phase 2 study of idelalisib plus rituximab in treatment naïve chronic lymphocytic leukemia (CLL) with del(17p). EHA. Jun 24 2017; 181752 Abstract.