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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.

british journal of haematology

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