This clinical trial focuses on studying Langerhans Cell Histiocytosis (LCH), a rare disease that can affect various parts of the body, including bones, skin, and organs. The study aims to find better ways to treat children and adolescents with this condition. The trial will use several medications, including Cladribine, Prednisolone, Fludarabine Phosphate, Cytarabine, Vinblastine Sulfate, Human Normal Immunoglobulin (IV), Mercaptopurine Monohydrate, Melphalan, Alemtuzumab, Indometacin, and Methotrexate. Some participants may receive a placebo as part of the study.
The purpose of the study is to reduce the risk of death in patients with multi-system LCH by quickly switching to alternative treatments if the first treatment does not work. The study will also explore whether extending or intensifying ongoing treatment can help reduce the chances of the disease coming back and prevent long-term problems. For patients with single-system LCH, the study will investigate if longer treatment can help prevent the disease from returning and reduce long-term issues.
Participants will follow a treatment plan that may include different combinations of the medications mentioned above. The study will last for a total of 24 months, with some treatments lasting for shorter periods. The goal is to achieve disease resolution, prevent reactivations, and minimize long-term consequences. The trial will also look at how well the treatments work and their safety. Participants will be monitored throughout the study to assess their response to the treatments and any side effects they may experience.



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