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Dose‐intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T‐cell leukaemia‐lymphoma: a randomized phase II study
Author(s) -
Ishida Takashi,
Jo Tatsuro,
Takemoto Shigeki,
Suzushima Hitoshi,
Uozumi Kimiharu,
Yamamoto Kazuhito,
Uike Naokuni,
Saburi Yoshio,
Nosaka Kisato,
Utsunomiya Atae,
Tobinai Kensei,
Fujiwara Hiroshi,
Ishitsuka Kenji,
Yoshida Shinichiro,
Taira Naoya,
Moriuchi Yukiyoshi,
Imada Kazunori,
Miyamoto Toshihiro,
Akinaga Shiro,
Tomonaga Masao,
Ueda Ryuzo
Publication year - 2015
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13338
Subject(s) - medicine , clinical endpoint , adverse effect , gastroenterology , rash , phases of clinical research , chemotherapy , clinical trial
Summary This multicentre, randomized, phase II study was conducted to examine whether the addition of mogamulizumab, a humanized anti‐ CC chemokine receptor 4 antibody, to mLSG 15, 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 mLSG 15 plus mogamulizumab or mLSG 15 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 mLSG 15‐plus‐mogamulizumab arm ( n = 29) were 52% [95% confidence interval ( CI ), 33–71%] and 86%, respectively; the corresponding values in the mLSG 15 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 mLSG 15‐plus‐mogamulizumab arm. Several adverse events, including skin disorders, cytomegalovirus infection, pyrexia, hyperglycaemia and interstitial lung disease, were observed only in the mLSG 15‐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.