Pilot study of hydroxyurea and methotrexate for recurrent Langerhans cell histiocytosis

Not Applicable

Recruiting

• Conditions: angerhans cell histiocytosis; Langerhans cell histiocytosis; D006646

• Registration Number: JPRN-jRCTs031220324
• Lead Sponsor: Shioda Yoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified