Pilot study to estimate the safety and effectiveness of hydroxyurea and methotrexate recurrent langerhans cell histiocytosis (LCH-HU-pilot)

This 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...

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Bibliographic Details
Published in:Medicine (Baltimore) 2022-12, Vol.101 (50), p.e31475-e31475
Main Authors: Sakamoto, Kenichi, Kikuchi, Kayoko, Sako, Mayumi, Kato, Miho, Takimoto, Tetsuya, Shioda, Yoko
Format: Article
Language:English
Subjects:
Histiocytosis, Langerhans-Cell - diagnosis
Humans
Hydroxyurea - adverse effects
Methotrexate - therapeutic use
Pilot Projects
Recurrence
Study Protocol Clinical Trial
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Description
Summary:This 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.
ISSN:1536-5964
0025-7974
1536-5964
DOI:10.1097/MD.0000000000031475