Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: A randomized phase II study

Takashi Ishida, Tatsuro Jo, Shigeki Takemoto, Hitoshi Suzushima, Kimiharu Uozumi, Kazuhito Yamamoto, Naokuni Uike, Yoshio Saburi, Kisato Nosaka, Atae Utsunomiya, Kensei Tobinai, Hiroshi Fujiwara, Kenji Ishitsuka, Shinichiro Yoshida, Naoya Taira, Yukiyoshi Moriuchi, Kazunori Imada, Toshihiro Miyamoto, Shiro Akinaga, Masao TomonagaRyuzo Ueda

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Abstract

This multicentre, randomized, phase II study was conducted to examine whether the addition of mogamulizumab, a humanized anti-CC chemokine receptor 4 antibody, to mLSG15, a dose-intensified chemotherapy, further increases efficacy without compromising safety of patients with newly diagnosed aggressive adult T-cell leukaemia-lymphoma (ATL). Patients were assigned 1:1 to receive mLSG15 plus mogamulizumab or mLSG15 alone. The primary endpoint was the complete response rate (%CR); secondary endpoints included the overall response rate (ORR) and safety. The %CR and ORR in the mLSG15-plus-mogamulizumab arm (n = 29) were 52% [95% confidence interval (CI), 33-71%] and 86%, respectively; the corresponding values in the mLSG15 arm (n = 24) were 33% (95% CI, 16-55%) and 75%, respectively. Grade ≥ 3 treatment-emergent adverse events, including anaemia, thrombocytopenia, lymphopenia, leucopenia and decreased appetite, were observed more frequently (≥10% difference) in the mLSG15-plus-mogamulizumab arm. Several adverse events, including skin disorders, cytomegalovirus infection, pyrexia, hyperglycaemia and interstitial lung disease, were observed only in the mLSG15-plus-mogamulizumab arm. Although the combination strategy showed a potentially less favourable safety profile, a higher %CR was achieved, providing the basis for further investigation of this novel treatment for newly diagnosed aggressive ATL. This study was registered at ClinicalTrials.gov, identifier: NCT01173887.

Original languageEnglish
Pages (from-to)672-682
Number of pages11
JournalBritish Journal of Haematology
Volume169
Issue number5
DOIs
Publication statusPublished - Jun 1 2015

All Science Journal Classification (ASJC) codes

  • Hematology

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    Ishida, T., Jo, T., Takemoto, S., Suzushima, H., Uozumi, K., Yamamoto, K., Uike, N., Saburi, Y., Nosaka, K., Utsunomiya, A., Tobinai, K., Fujiwara, H., Ishitsuka, K., Yoshida, S., Taira, N., Moriuchi, Y., Imada, K., Miyamoto, T., Akinaga, S., ... Ueda, R. (2015). Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: A randomized phase II study. British Journal of Haematology, 169(5), 672-682. https://doi.org/10.1111/bjh.13338