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LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512676-36-00
Acronym
042011
Enrollment
1124
Registered
2024-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Langerhans Cell Histiocytosis

Brief summary

Reactivation-free survival, Overall and disease free survival, To study the course of neurodegenerative CNS-LCH, Response of isolated tumorous CNS lesions to 2-CdA, Rate and spectrum of permanent consequences

Detailed description

Incidence of permanent consequences, Toxicity of treatment, Proportion fo patients alive and free of disease without permanent consequences, Cumulative incidence of reactivations in risk organs

Interventions

DRUGVinblastine Sulfate 1 mg/ml Solution for Injection or Infusion
DRUGOCTAGAM 10 %
DRUGLösung zur intravenösen Infusion
DRUGMercaptopurine Silver Pharma 50 mg tablets
DRUGINDOMETACIN CAPSULES BP 25mg
DRUGMethotrexate 10 mg Tablets

Sponsors

St. Anna Childrens Cancer Research Institute GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Reactivation-free survival, Overall and disease free survival, To study the course of neurodegenerative CNS-LCH, Response of isolated tumorous CNS lesions to 2-CdA, Rate and spectrum of permanent consequences

Secondary

MeasureTime frame
Incidence of permanent consequences, Toxicity of treatment, Proportion fo patients alive and free of disease without permanent consequences, Cumulative incidence of reactivations in risk organs

Countries

Austria, Belgium, Czechia, Denmark, Greece, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026