A phase II trial of bendamustine in combination with ofatumumab in patients with relapsed or refractory marginal zone B-cell lymphomas.


Journal

Hematological oncology
ISSN: 1099-1069
Titre abrégé: Hematol Oncol
Pays: England
ID NLM: 8307268

Informations de publication

Date de publication:
Feb 2021
Historique:
received: 02 09 2020
revised: 12 10 2020
accepted: 19 10 2020
pubmed: 27 10 2020
medline: 3 3 2021
entrez: 26 10 2020
Statut: ppublish

Résumé

Marginal zone lymphomas (MZLs) are indolent yet incurable lymphomas with frequent relapses following therapy. For patients with relapsed/refractory disease, no standard therapies exist. Here we report results of an exploratory phase II study aimed at assessing the efficacy and safety of the alkylator agent bendamustine in combination with the second-generation anti-CD20 monoclonal antibody, ofatumumab, in patients with relapsed or refractory MZL. Patients with MZL and previously treated with at least one line of systemic therapy were eligible. Treatment consisted in bendamustine (90 mg/m

Identifiants

pubmed: 33103778
doi: 10.1002/hon.2822
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Bendamustine Hydrochloride 981Y8SX18M
ofatumumab M95KG522R0

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

60-65

Subventions

Organisme : Mundipharma Medical Company and Novartis Farma S.p.A provided the two drugs free of charge
Organisme : Novartis Farma S.p.A provided also partial financial support for the study.

Informations de copyright

© 2020 John Wiley & Sons Ltd.

Références

Vannata B, Stathis A, Zucca E. Management of the marginal zone lymphomas. Cancer Treat Res. 2015;165:227-249.
Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127:2375-2390.
Noy A, de Vos S, Thieblemont C, et al. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017;129:2224-2232.
Advani RH, Buggy JJ, Sharman JP, et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013;31:88-94.
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.
Barth MJ, Mavis C, Czuczman MS, Hernandez-Ilizaliturri FJ. Ofatumumab exhibits enhanced in vitro and in vivo activity compared to rituximab in preclinical models of mantle cell lymphoma. Clin Cancer Res. 2015;21:4391-4397.
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;156:490-498.
Hagenbeek A, Gadeberg O, Johnson P, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008;111:5486-5495.
Coiffier B, Lepretre S, Pedersen LM, et al. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. 2008;111:1094-1100.
Robak T, Warzocha K, Govind Babu K, et al. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Leuk Lymphoma. 2017;58:1084-1093.
Cheson BD. Ofatumumab, a novel anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. J Clin Oncol. 2010;28:3525-3530.
Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579-586.
Matutes E, Oscier D, Montalban C, et al. Splenic marginal zone lymphoma proposals for a revision of diagnostic, staging and therapeutic criteria. Leukemia. 2008;22:487-495.
Copie-Bergman C, Gaulard P, Lavergne-Slove A, et al. Proposal for a new histological grading system for post-treatment evaluation of gastric MALT lymphoma. Gut. 2003;52:1656.
Czuczman MS, Kahanic S, Forero A, et al. Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma. Ann Hematol. 2015;94:633-641.
Kiesewetter B, Neuper O, Mayerhoefer ME, et al. A pilot phase II study of ofatumumab monotherapy for extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue (MALT) lymphoma. Hematol Oncol. 2018;36:49-55.
Herold M, Hoster E, Janssens A, et al. Immunochemotherapy with obinutuzumab or rituximab in a subset of patients in the randomised gallium trial with previously untreated marginal zone lymphoma (MZL). Hematol Oncol. 2017;35:146-147.
Conconi A, Martinelli G, Thieblemont C, et al. Clinical activity of rituximab in extranodal marginal zone B-cell lymphoma of MALT type. Blood. 2003;102:2741-2745.
Hammel P, Haioun C, Chaumette MT, et al. Efficacy of single-agent chemotherapy in low-grade B-cell mucosa-associated lymphoid tissue lymphoma with prominent gastric expression. J Clin Oncol. 1995;13:2524-2529.
Kalpadakis C, Pangalis GA, Sachanas S, et al. Rituximab monotherapy in splenic marginal zone lymphoma: prolonged responses and potential benefit from maintenance. Blood. 2018;132:666-670.
Martinelli G, Laszlo D, Ferreri AJ, et al. Clinical activity of rituximab in gastric marginal zone non-Hodgkin's lymphoma resistant to or not eligible for anti-Helicobacter pylori therapy. J Clin Oncol. 2005;23:1979-1983.
Iannitto E, Bellei M, Amorim S, et al. Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study. Br J Haematol. 2018;183:755-765.
Salar A, Domingo-Domenech E, Panizo C, et al. First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014;1:e104-e111.
Salar A, Domingo-Domenech E, Panizo C, et al. Long-term results of a phase 2 study of rituximab and bendamustine for mucosa-associated lymphoid tissue lymphoma. Blood. 2017;130:1772-1774.
Zucca E, Conconi A, Martinelli G, et al. Final results of the IELSG-19 randomized trial of mucosa-associated lymphoid tissue lymphoma: improved event-free and progression-free survival with rituximab plus chlorambucil versus either chlorambucil or rituximab monotherapy. J Clin Oncol. 2017;35:1905-1912.
Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-kinase inhibition by Copanlisib in relapsed or refractory indolent lymphoma. J Clin Oncol. 2017;35:3898-3905.
Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a phase II study of Duvelisib (IPI-145) in patients with refractory indolent non-Hodgkin lymphoma. J Clin Oncol. 2019;37:912-922.
Forero-Torres A, Ramchandren R, Yacoub A, et al. Parsaclisib, a potent and highly selective PI3Kdelta inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood. 2019;133:1742-1752.
Burris HA, 3rd, Flinn IW, Patel MR, et al. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018;19:486-496.
Di Bella N, Taetle R, Kolibaba K, et al. Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma. Blood. 2010;115:475-480.
Conconi A, Martinelli G, Lopez-Guillermo A, et al. Clinical activity of bortezomib in relapsed/refractory MALT lymphomas: results of a phase II study of the International Extranodal Lymphoma Study Group (IELSG). Ann Oncol. 2011;22:689-695.
Kiesewetter B, Troch M, Dolak W, et al. A phase II study of lenalidomide in patients with extranodal marginal zone B-cell lymphoma of the mucosa associated lymphoid tissue (MALT lymphoma). Haematologica. 2013;98:353-356.
Leonard JP, Trneny M, Izutsu K, et al. AUGMENT: a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. J Clin Oncol. 2019;37:1188-1199.

Auteurs

Barbara Vannata (B)

Lymphoma Unit, Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland.

Anna Vanazzi (A)

Division of Clinical Hemato-Oncology, European Institute of Oncology (IEO) IRCCS, Milan, Italy.

Mara Negri (M)

Division of Clinical Hemato-Oncology, European Institute of Oncology (IEO) IRCCS, Milan, Italy.

Sarah Jayne Liptrott (SJ)

Division of Clinical Hemato-Oncology, European Institute of Oncology (IEO) IRCCS, Milan, Italy.

Anna Amalia Bartosek (AA)

Nerviano Medical Sciences S.r.l, Nerviano, Milan, Italy.

Monica Miani (M)

Nerviano Medical Sciences S.r.l, Nerviano, Milan, Italy.

Alessandro Di Sanzo (A)

Nerviano Medical Sciences S.r.l, Nerviano, Milan, Italy.

Franco Cavalli (F)

Lymphoma Unit, Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland.
Faculty of Biomedical Sciences, Institute of Oncology Research (IOR), Bellinzona, Switzerland.

Emanuele Zucca (E)

Lymphoma Unit, Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland.
Faculty of Biomedical Sciences, Institute of Oncology Research (IOR), Bellinzona, Switzerland.

Anastasios Stathis (A)

Lymphoma Unit, Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland.
Faculty of Biomedical Sciences, Università della Svizzera italiana (USI), Lugano, Switzerland.

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