Phase I/II study of bendamustine in combination with ofatumumab, carboplatin, etoposide (BOCE) for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

References

• Philip T, Guglielmi C, Hagenbeek A, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995;333(23):1540–1545.
   PubMed Web of Science ®Google Scholar
• Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;28(27):4184–4190.
   PubMed Web of Science ®Google Scholar
• Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20(1):31–42.
   PubMed Web of Science ®Google Scholar
• Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):45–56.
   PubMed Web of Science ®Google Scholar
• Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800–1808.
   PubMed Web of Science ®Google Scholar
• Crump M, Kuruvilla J, Couban S, et al. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014;32(31):3490–3496.
   PubMed Web of Science ®Google Scholar
• Mounier N, El Gnaoui T, Tilly H, et al. Rituximab plus gemcitabine and oxaliplatin in patients with refractory/relapsed diffuse large B-cell lymphoma who are not candidates for high-dose therapy. A phase II lymphoma study association trial. Haematologica. 2013;98(11):1726–1731.
   PubMed Web of Science ®Google Scholar
• Kewalramani T, Zelenetz AD, Nimer SD, et al. Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma. Blood. 2004;103(10):3684–3688.
   PubMed Web of Science ®Google Scholar
• Weidmann E, Kim SZ, Rost A, et al. Bendamustine is effective in relapsed or refractory aggressive non-Hodgkin's lymphoma. Ann Oncol. 2002;13(8):1285–1289.
   PubMed Web of Science ®Google Scholar
• Leoni LM, Bailey B, Reifert J, et al. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res. 2008;14(1):309–317.
   PubMed Web of Science ®Google Scholar
• Flinn IW, van der Jagt R, Kahl BS, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014;123(19):2944–2952.
   PubMed Web of Science ®Google Scholar
• Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013;381(9873):1203–1210.
   PubMed Web of Science ®Google Scholar
• 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(6):1793–1800.
   PubMed Web of Science ®Google Scholar
• Bologna L, Gotti E, Da Roit F, et al. Ofatumumab is more efficient than rituximab in lysing B chronic lymphocytic leukemia cells in whole blood and in combination with chemotherapy. J Immunol. 2013;190(1):231–239.
   PubMed Web of Science ®Google Scholar
• Coiffier B, Radford J, Bosly A, et al. A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. Br J Haematol. 2013;163(3):334–342.
   PubMed Web of Science ®Google Scholar
• Haskova Z, Whitacre MN, Dede KA, et al. Combination therapy with ofatumumab and bendamustine in xenograft model of chronic lymphocytic leukaemia. Br J Haematol. 2012;156(3):402–404.
   PubMed Web of Science ®Google Scholar
• van Imhoff GW, McMillan A, Matasar MJ, et al. Ofatumumab versus rituximab salvage chemoimmunotherapy in relapsed or refractory diffuse large B-Cell lymphoma: the ORCHARRD study. J Clin Oncol. 2017;35(5):544–551.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25(5):579–586.
   PubMed Web of Science ®Google Scholar
• Storer BE. Design and analysis of phase I clinical trials. Biometrics. 1989;45(3):925–937.
   PubMed Web of Science ®Google Scholar
• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1–10.
   PubMedGoogle Scholar
• Hans CP, Weisenburger DD, Greiner TC, et al. Confirmation of the molecular classification of diffuse large B-cell lymphoma by immunohistochemistry using a tissue microarray. Blood. 2004;103(1):275–282.
   PubMed Web of Science ®Google Scholar
• Green DJ, Bensinger WI, Holmberg LA, et al. Bendamustine, etoposide and dexamethasone to mobilize peripheral blood hematopoietic stem cells for autologous transplantation in patients with multiple myeloma. Bone Marrow Transplant. 2016;51(10):1330–1336.
   PubMed Web of Science ®Google Scholar
• Budde LE, Wu D, Martin DB, et al. Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial. Br J Haematol. 2018;183(4):601–607.
   PubMed Web of Science ®Google Scholar
• Barth MJ, Hernandez-Ilizaliturri FJ, Mavis C, et al. Ofatumumab demonstrates activity against rituximab-sensitive and -resistant cell lines, lymphoma xenografts and primary tumour cells from patients with B-cell lymphoma. Br J Haematol. 2012;156(4):490–498.
   PubMed Web of Science ®Google Scholar
• Matasar MJ, Czuczman MS, Rodriguez MA, et al. Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma. Blood. 2013;122(4):499–506.
   PubMed Web of Science ®Google Scholar