CH-IIITreatment Protocol of the Third International Study for LANGERHANS CELL HISTIOCYTOSIS - LCH-III

• Conditions: angerhans cell Histiocytosis; MedDRA version: 14.1Level: HLTClassification code 10020118Term: HistiocytosesSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2006-002388-15-IT
• Lead Sponsor: AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE OSPEDALE CIVICO E BENFRATELLI, G.DI CRISTINA E M.ASCOLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Age < 18 years
Histological diagnosis
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of intesification of therapy with MTX in multisystem LCH; to evaluate the efficacy of extended duration of therapy for non-localized LCH;Secondary Objective: Reduction of the numebr of sequelae;Primary end point(s): Survival