Risk Stratified Clinical Research on Children and Young Adult with Newly Diagnosed Langerhans cell Histiocytosis

Risk Stratified Clinical Research on Children and Young Adult with Newly Diagnosed Langerhans cell Histiocytosis - LCH-12

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008067

Enrollment

130

Registered

2012-06-01

Start date

2012-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Langerhans cell histiocytosis

Interventions

Multiple bone type: Induction A (6 weeks) and Early maintenance A (24 weeks) Multi-system type: Induction A (6 weeks)Patients who had response to Induction A (GR / PR): Early maintenance A (24 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologicaly diagnosed LCH 2. Patients whose biopsied specimens can be submitted for central diagnosis review within two weeks from registration to the clinical study

Exclusion criteria

Exclusion criteria: 1. Patients other than Multiple bone or Multi-system type LCH 2. Patients with organ failure which make difficult to carry out the treatment 3. Patients receiving other treatment except steroids or surgical treatment for LCH 4. Patients with neurodegenerative LCH 5. Patients with any severe bleeding in CNS system 6. Patients with an uncontrolled systemic infection 7. Pregnant women 8. Lactating women 9. Patients whose body weight is less than 2500g 10. Patients with history or concurrent malignancy 11. Patients with a congenital or acquired immunodeficiency syndrome. 12. Informed consent is not obtained from patients and / or the guardians for treatment LCH-12 13. Age is greater than or equal to 20 years old at the start of treatment 14. When the doctor determines that the other inappropriate

Design outcomes

Primary

Measure	Time frame
Event-free survival rates in different type of disease.	—

Secondary

Measure	Time frame
Incidence of an adverse event. Overall survival rates A response rate of remission induction phase. The validity of the LCH disease clinical score. The incidence of irreversible lesions. Event-free survival rates in all registered cases, including the clinical trials excluded patients. Overall survival rates in all registered cases, including the clinical trials excluded patients. Incidence of irreversible lesions in all registered cases, including the clinical trials excluded patients. Analysis of humoral factors to reflect the disease activity and prognosis of LCH in all registered cases, including the clinical trials excluded patients.	—

Measure

Time frame

Incidence of an adverse event. Overall survival rates A response rate of remission induction phase. The validity of the LCH disease clinical score. The incidence of irreversible lesions. Event-free survival rates in all registered cases, including the clinical trials excluded patients. Overall survival rates in all registered cases, including the clinical trials excluded patients. Incidence of irreversible lesions in all registered cases, including the clinical trials excluded patients. Analysis of humoral factors to reflect the disease activity and prognosis of LCH in all registered cases, including the clinical trials excluded patients.

—

Countries

Japan

Contacts

Public ContactAkira Morimoto

Jichi Medical University Department of Pediatrics, Children's Medical center Tochigi

akira@jichi.ac.jp0285-58-7366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026