Curr Hematol Malig Rep (2012) 7:235–240 Therefore, it may provide an effective treatment option for the disease, especially for elderly patients who are not eligible for intensive chemotherapy or hematopoietic stem-cell transplantation. In Japan, based on the results of the clinical studies mentioned above, a single-arm phase II study of mogamu- lizumab monotherapy in patients with CTCL and PTCL (ClinicalTrials.gov Identifier: NCT01192984) and a random- ized phase II study of dose-intensified combination chemo- therapy (mLSG15 regimen) with or without mogamulizumab in untreated patients with ATL (ClinicalTrials.gov Identifier: NCT01173887) are being conducted as shown in Fig. 1. Patient enrollment has already been completed in these phase II studies. In the U.S., based on the aforementioned phase I/II study in patients with relapsed or refractory CTCL, a pivotal phase III study in patients with relapsed or refractory CTCL is being planned. In conclusion, mogamulizumab is expected to provide new, promising treatment options in patients with ATL and other T-cell lymphomas. Acknowledgments We thank all the investigators who participated in the multicenter clinical trials of mogamulizumab/KW-0761 in Japan. Clinical studies of mogamulizumab were sponsored by Kyowa Hakko Kirin Co. Ltd., Tokyo, Japan. Disclosure K. Tobinai: research grant from Kyowa Hakko Kirin Co. Ltd. and board membership for Merck, Mundipharma, Zenyaku, Genzyme, Eisai, Symbio, Eli Lilly, Celgene, Kyowa-Kirin, Biomedics, and Solasia Pharma; T. Takahashi: employee of Kyowa Hakko Kirin Co. Ltd.; S. Akinaga: employee of Kyowa Hakko Kirin Co. Ltd. Open Access This article is distributed under the terms of the Crea- tive Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. 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