A phase 2 study of inotuzumab ozogamicin and rituximab, followed by autologous stem cell transplant in patients with relapsed/refractory diffuse large B-cell lymphoma

Nina D. Wagner-Johnston, Andrè Goy, Maria A. Rodriguez, W. Christopher Ehmann, Paul A. Hamlin, John Radford, Catherine Thieblemont, Cheolwon Suh, John Sweetenham, Yifan Huang, Sharon T. Sullivan, Erik R. Vandendries, Christian Gisselbrecht

Research output: Contribution to journalArticle

20 Scopus citations

Abstract

This study evaluated the safety and efficacy of inotuzumab ozogamicin (INO), a targeted humanized anti-CD22 antibody conjugated to calicheamicin, plus rituximab (R-INO) every 3 weeks, up to six cycles, followed by high dose therapy and autologous stem cell transplant (HDT-aSCT) in patients with high-risk relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was overall response (OR) rate after three cycles of R-INO. Sixty-three patients were enrolled. Common grade 3/4 adverse events during R-INO treatment were thrombocytopenia, lymphopenia and neutropenia. OR rate after three cycles of R-INO was 28.6% (95% confidence interval: 17.9-41.4). Eighteen patients underwent HDT-aSCT; 2-year progression-free survival (PFS) for these patients was 61.1%. Serious infections and hepatic toxicity following aSCT occurred in 33% and 22%, respectively. One- and 2-year PFS rates for all enrolled patients were 28.9% and 25.3%, respectively (median, 3.0 months). R-INO had lower than expected activity as a salvage regimen for transplant eligible patients with DLBCL.

Original languageEnglish (US)
Pages (from-to)2863-2869
Number of pages7
JournalLeukemia and Lymphoma
Volume56
Issue number10
DOIs
StatePublished - Oct 3 2015
Externally publishedYes

Keywords

  • DLBCL
  • Inotuzumab ozogamicin
  • autologous
  • immunotherapy
  • rituximab
  • transplant

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Wagner-Johnston, N. D., Goy, A., Rodriguez, M. A., Ehmann, W. C., Hamlin, P. A., Radford, J., Thieblemont, C., Suh, C., Sweetenham, J., Huang, Y., Sullivan, S. T., Vandendries, E. R., & Gisselbrecht, C. (2015). A phase 2 study of inotuzumab ozogamicin and rituximab, followed by autologous stem cell transplant in patients with relapsed/refractory diffuse large B-cell lymphoma. Leukemia and Lymphoma, 56(10), 2863-2869. https://doi.org/10.3109/10428194.2015.1017821