LCH-A1, first international study for Langerhans Cell Histiocytosis in adults - LCH-A1

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002392-40-NL

Enrollment

1200

Registered

2007-08-09

Start date

2007-10-05

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Langerhans Cell Histiocytosis in adults with single system disease with multifocal bonelesions or with lesions in the craniofacial bones with brain extension or in the vertebral bones with intraspinal tumor extension

Interventions

Trade Name: Prednisone Product Name: Prednison Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: 53032 Concentration unit: mg milligram(s) Product Name: Vinblastine Product Code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - definitive diagnosis of LCH - no prior cytoreductive treatment for LCH Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients with severe impairment of clinical condition including severely impaired pulmonary function, longterm oxygen therapy or cor pulmonale - treatment with immune suppresive agents or biphosphonates within 4 weeks from baseline evaluation - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: to define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment for patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of disease and ;Secondary Objective: ;Primary end point(s): definition and implementation of an uniform treatment for patients with single system LCH, multisystem LCH and isolated pulmonary LCH, implementation of uniform initial evaluation and stratification criteria.	—

Measure

Time frame

Main Objective: to define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment for patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of disease and ;Secondary Objective: ;Primary end point(s): definition and implementation of an uniform treatment for patients with single system LCH, multisystem LCH and isolated pulmonary LCH, implementation of uniform initial evaluation and stratification criteria.

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Countries

Netherlands

Outcome results

None listed

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