Pilot study to estimate the safety and effectiveness of hydroxyurea and methotrexate recurrent Langerhans cell histiocytosis - LCH-HU-Pilot

Shioda Yoko0 sites10 target enrollmentSeptember 8, 2022

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shioda Yoko

•Relapsed patients with Langerhans cell histiocytosis
•1\. Capsule formulation must be able to be taken internally.
•2\. Histopathologically diagnosed with LCH at the time of initial or recurrent disease.
•3\. The LCH disease is recurrent (regardless of the number of recurrences). \*Central diabetes insipidus alone is excluded.
•4\. Treatment for the recurrence has not been initiated (local treatment is excluded).
•5\. No LCH involvement of risk organs (liver, spleen, hematopoietic organs).
•6\. No hemophagocytic lymphohistiocytosis (HLH) complication at the time of relapse
•7\. Adequate hepatic, renal, cardiac, and pulmonary function at study entry.
•8\. Patients have a general status of 0 to 2 on the Performance status (PS) scale.

•1\. Cases with recurrence of Central diabetes insipidus alone
•2\. Cases with active infection
•3\. Patients with active multiple cancers
•4\. Pregnant or lactating women
•5\. Patients of childbearing potential
•6\. Patients with active bleeding at the time of enrollment
•7\. Patients with active CNS symptoms at the time of enrollment (excluding symptoms caused by LCH itself)
•8\.Patients who have received hydroxyurea for LCH
•9\. Other cases deemed inappropriate by the investigators/associate investigators.