Treatment protocol of the first international study for Langerhans Cell Histiocytosis in Adults

Recruiting

• Conditions: angerhans Cell Histiocytosis; Langerhans Cel Histiocytose

• Registration Number: NL-OMON24739
• Lead Sponsor: VU University Medical Center Amsterdam,Department of Hematology

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1200

Inclusion Criteria

1. definitive diagnosis of LCH

2. no prior cytoreductive treatment for LCH

Exclusion Criteria

1. patients with severe impairment of clinical condition including severely impaired pulmonary function, long term oxygen therapy or cor pulmonale.

2. treatment with immune suppressive agents and/or bisphosphonates within 4 weeks from baseline evaluation 3. pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definition and implementation of an uniform treatment for patients with single system LCH, multisystem LCH and pulmonary isolated LCH; implementation of uniform initial evaluation and stratification criteria.

Secondary Outcome Measures

Name	Time	Method
- to explore the therapeutic efficacy on adult patients of the standard regimen for multisystem LCH in children, i.e. the combination of vinblastine and prednisone.<br>Endpoints will be survival, reactivation-free survival, permanent sequelae.<br /><br>- to examine if an extended continuation therapy may reduce disease reactivations occuring after treatment completion in patients with multisystem LCH.<br /><br>- to describe the natural history of isolated pulmonary disease and in particular the role of smoking cessation on the disease course. <br /><br>- to explore the therapeutic efficacy of steroid monotherapy in adult patients with isolated pulmonary disease showing disease progression.