-
Multicenter Study
Pilot study to estimate the safety and effectiveness of hydroxyurea and methotrexate recurrent langerhans cell histiocytosis (LCH-HU-pilot).
- Kenichi Sakamoto, Kayoko Kikuchi, Mayumi Sako, Miho Kato, Tetsuya Takimoto, and Yoko Shioda.
- Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.
- Medicine (Baltimore). 2022 Dec 16; 101 (50): e31475e31475.
AbstractThis study was a non-blinded, multicenter, single-arm study. Recurrent (relapsed) LCH is defined as the appearance of new lesions or the enlargement of preexisting lesions due to LCH. In this study, all patients received hydroxyurea, and if the treatment response was unsatisfactory, methotrexate was added. The duration of treatment was 48 weeks. The primary endpoint was the rate of non-active disease achievement, which was 24 weeks after initiating hydroxyurea administration. No active disease is defined as the resolution of all the signs and symptoms related to LCH.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.
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