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Phase IA/II, multicentre, open-label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non-Hodgkin or Hodgkin lymphoma

(2014) BRITISH JOURNAL OF HAEMATOLOGY. 164(2). p.258-265
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Abstract
Despite advancements in the treatment of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8-week cycle. MTD was determined at 4mg/kg of lucatumumab. A total of 111 patients with NHL (n=74) and HL (n=37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa-associated lymphatic tissue (MZL/MALT) was 33.3% and 42.9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.
Keywords
Hodgkin lymphoma, non-Hodgkin lymphoma, monoclonal antibodies, CHRONIC LYMPHOCYTIC-LEUKEMIA, REED-STERNBERG CELLS, ANTIGEN-EXPRESSION, ANTI-CD40, DACETUZUMAB, RITUXIMAB, DISEASE, EFFICACY, CRITERIA, LIGAND

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Citation

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MLA
Fanale, Michelle, Sarit Assouline, John Kuruvilla, et al. “Phase IA/II, Multicentre, Open-label Study of the CD40 Antagonistic Monoclonal Antibody Lucatumumab in Adult Patients with Advanced non-Hodgkin or Hodgkin Lymphoma.” BRITISH JOURNAL OF HAEMATOLOGY 164.2 (2014): 258–265. Print.
APA
Fanale, M., Assouline, S., Kuruvilla, J., Solal-Céligny, P., Heo, D. S., Verhoef, G., Corradini, P., et al. (2014). Phase IA/II, multicentre, open-label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non-Hodgkin or Hodgkin lymphoma. BRITISH JOURNAL OF HAEMATOLOGY, 164(2), 258–265.
Chicago author-date
Fanale, Michelle, Sarit Assouline, John Kuruvilla, Philippe Solal-Céligny, Dae S Heo, Gregor Verhoef, Paolo Corradini, et al. 2014. “Phase IA/II, Multicentre, Open-label Study of the CD40 Antagonistic Monoclonal Antibody Lucatumumab in Adult Patients with Advanced non-Hodgkin or Hodgkin Lymphoma.” British Journal of Haematology 164 (2): 258–265.
Chicago author-date (all authors)
Fanale, Michelle, Sarit Assouline, John Kuruvilla, Philippe Solal-Céligny, Dae S Heo, Gregor Verhoef, Paolo Corradini, Jeremy S Abramson, Fritz Offner, Andreas Engert, Martin JS Dyer, Daniel Carreon, Brett Ewald, Johan Baeck, Anas Younes, and Arnold S Freedman. 2014. “Phase IA/II, Multicentre, Open-label Study of the CD40 Antagonistic Monoclonal Antibody Lucatumumab in Adult Patients with Advanced non-Hodgkin or Hodgkin Lymphoma.” British Journal of Haematology 164 (2): 258–265.
Vancouver
1.
Fanale M, Assouline S, Kuruvilla J, Solal-Céligny P, Heo DS, Verhoef G, et al. Phase IA/II, multicentre, open-label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non-Hodgkin or Hodgkin lymphoma. BRITISH JOURNAL OF HAEMATOLOGY. 2014;164(2):258–65.
IEEE
[1]
M. Fanale et al., “Phase IA/II, multicentre, open-label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non-Hodgkin or Hodgkin lymphoma,” BRITISH JOURNAL OF HAEMATOLOGY, vol. 164, no. 2, pp. 258–265, 2014.
@article{5792353,
  abstract     = {Despite advancements in the treatment of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), patients continue to relapse and thus a need for new targeted therapies remains. The CD40 receptor is highly expressed on neoplastic B cells and activation leads to enhanced proliferation and survival. Lucatumumab (HCD122) is a fully human antagonistic CD40 monoclonal antibody. A phase IA/II study was designed to determine the maximum tolerated dose (MTD) and activity of lucatumumab in patients with relapsed/refractory lymphoma. Determination of the MTD was the primary objective of the phase IA dose escalation portion and clinical response was the primary objective of the phase II dose expansion portion. Patients received escalating doses of lucatumumab administered intravenously once weekly for 4 weeks of an 8-week cycle. MTD was determined at 4mg/kg of lucatumumab. A total of 111 patients with NHL (n=74) and HL (n=37) were enrolled. Responses were observed across various lymphoma subtypes. The overall response rate by computed tomography among patients with follicular lymphoma (FL) and marginal zone lymphoma of mucosa-associated lymphatic tissue (MZL/MALT) was 33.3% and 42.9%, respectively. Lucatumumab demonstrates modest activity in relapsed/refractory patients with advanced lymphoma, suggesting that targeting of CD40 warrants further investigation.},
  author       = {Fanale, Michelle and Assouline, Sarit and Kuruvilla, John and Solal-Céligny, Philippe and Heo, Dae S and Verhoef, Gregor and Corradini, Paolo and Abramson, Jeremy S and Offner, Fritz and Engert, Andreas and Dyer, Martin JS and Carreon, Daniel and Ewald, Brett and Baeck, Johan and Younes, Anas and Freedman, Arnold S},
  issn         = {0007-1048},
  journal      = {BRITISH JOURNAL OF HAEMATOLOGY},
  keywords     = {Hodgkin lymphoma,non-Hodgkin lymphoma,monoclonal antibodies,CHRONIC LYMPHOCYTIC-LEUKEMIA,REED-STERNBERG CELLS,ANTIGEN-EXPRESSION,ANTI-CD40,DACETUZUMAB,RITUXIMAB,DISEASE,EFFICACY,CRITERIA,LIGAND},
  language     = {eng},
  number       = {2},
  pages        = {258--265},
  title        = {Phase IA/II, multicentre, open-label study of the CD40 antagonistic monoclonal antibody lucatumumab in adult patients with advanced non-Hodgkin or Hodgkin lymphoma},
  url          = {http://dx.doi.org/10.1111/bjh.12630},
  volume       = {164},
  year         = {2014},
}

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