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A study to determine efficacy of prolonged maintenance therapy in children with multi-system Langerhans cell histiocytosis

A study on the standardized diagnosis, treatment and evaluation of Langerhans cell histiocytosis in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032677
Enrollment
Unknown
Registered
2020-05-06
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Langerhans cell histiocytosis

Interventions

Control group:Total course of treatment 12 months
Experimental group: The maintenance treatment course was prolonged to make the total treatment course up to 18 months.

Sponsors

Beijing Children's Hospital, Capital Medical University, National Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: All the following criteria must be met: 1. Patients were diagnosed as LCH by clinical and pathological examination from May 2020 to December 2025; 2. Two or more organs or systems were involved, and no dangerous organs (liver, spleen, hematopoietic system) were involved at diagnosis; 3. Patients were not treated by any anti-tumor treatment before diagnosis; 4. Patients were less than 18 years of age; 5. Informed consent were obtained from guardians of the patients and the patients (more than 8 years old).

Exclusion criteria

Exclusion criteria: If one of the following conditions exists, he/she will not be included in this study: 1. Patients who can't carry out systematic treatment according to the standardized diagnosis and treatment protocol; 2. Patients who can't carry out the treatment according to the established protocol due to personal reasons during the treatment; 3. Those who have any significant abnormal coexisting diseases or mental diseases that affect the life safety and compliance of patients, and informed consent, research participation, follow-up or result interpretation.

Design outcomes

Primary

MeasureTime frame
Event-free survival;Progression-free Survival;Cumulative incidence of relapse;Cumulative incidence of permanent consequences;

Secondary

MeasureTime frame
6-week response rate;6-week response rate;Hazard ratio;Overall survival;Tissue BRAF mutations;cell-free BRAF mutations;Dynamic changes of key biomarkers during treatment;Adverse events;

Countries

China

Contacts

Public ContactRui Zhang

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health

ruizh1973@126.com+86 18611106187

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026