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Br J Haematol. 2015 Jun;169(5):672-82. doi: 10.1111/bjh.13338. Epub 2015 Mar 2.

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

Author information

1
Department of Haematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
2
Department of Haematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
3
Department of Haematology and Institute for Clinical Research, National Hospital Organization Kumamoto Medical Centre, Kumamoto, Japan.
4
Department of Haematology, Kumamoto Shinto General Hospital, Kumamoto, Japan.
5
Department of Haematology and Immunology, Kagoshima University Hospital, Kagoshima, Japan.
6
Department of Haematology and Cell Therapy, Aichi Cancer Centre Hospital, Nagoya, Japan.
7
Department of Haematology, National Hospital Organization Kyushu Cancer Centre, Fukuoka, Japan.
8
Department of Haematology, Oita Prefectural Hospital, Oita, Japan.
9
Cancer Centre, Kumamoto University Hospital, Kumamoto, Japan.
10
Department of Haematology, Imamura Bun-in Hospital, Kagoshima, Japan.
11
Department of Haematology, National Cancer Centre Hospital, Tokyo, Japan.
12
Department of Bioregulatory Medicine, Ehime University Graduate School of Medicine, Toon, Japan.
13
Division of Medical Oncology, Haematology, and Infectious Diseases, Department of Internal Medicine, Fukuoka University, Fukuoka, Japan.
14
Department of Haematology, National Hospital Organization Nagasaki Medical Centre, Ohmura, Japan.
15
Department of Internal Medicine, Heartlife Hospital, Okinawa, Japan.
16
Department of Haematology, Sasebo City General Hospital, Sasebo, Japan.
17
Department of Haematology, Kokura Memorial Hospital, Kitakyushu, Japan.
18
Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
19
Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
20
Department of Tumour Immunology, Aichi Medical University School of Medicine, Nagoya, Japan.

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.

KEYWORDS:

CCR4; adult T-cell leukaemia-lymphoma; antibody therapy; mogamulizumab; randomized phase II study

PMID:
25733162
PMCID:
PMC5024033
DOI:
10.1111/bjh.13338
[Indexed for MEDLINE]
Free PMC Article

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