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Precise stratified treatment of Langerhans cell histiocytosis in children

Precise stratified treatment of Langerhans cell histiocytosis in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033440
Enrollment
Unknown
Registered
2020-06-01
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

Langerhans cell histiocytosis

Interventions

Experimental group:Based on an accurate risk stratification system including the levels of plasma cfBRAF-V600E, LCH patients were treated by the first-line therapy (Prednisone, Vindesine), the second-
Control group:According to the conventional evaluation system of involved organs, LCH patients were treated by the first-line therapy, the second-line therapy and the maintenance therapy.

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: (1) Patients were diagnosed as LCH by clinical and pathological examination in our hospital; (2) Patients aged less than 18 years; (3) Informed consent were obtained from guardians of the patients and the patients (more than 8 years old).

Exclusion criteria

Exclusion criteria: (1) Patient who had received any anti-tumor treatment before diagnosis; (2) Patient who was allergic to any drug included in this study; (3) Patients who can't perform the treatment according to the standardized protocol of this study; (4) Patient who was unable to comply during the trial and / or follow-up phase.

Design outcomes

Primary

MeasureTime frame
Progression-free Survival;Event-free survival;Cumulative incidence of relapse;Response rate;Efficacy index for judging prognosis by a new type of risk stratification system;

Secondary

MeasureTime frame
Cumulative incidence of permanent consequences;Negative conversion rate of cfBRAF-V600E in plasma;Hazard ratio;Overall survival;Tissue BRAF mutations;Dynamic changes of key biomarkers during treatment;

Countries

China

Contacts

Public ContactRui Zhang

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

ruizh1973@126.com+86 18611106187

Outcome results

None listed

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