Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Phase 1

• Conditions: angerhans cell histiocytosis; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-001699-20-ES
• Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

? Definitive diagnosis of Langerhans cell histiocytosis
? Age less 18 years at time of definitive diagnosis
? Met inclusion criteria for the respective stratum
? Signed written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 1100
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

- Stratum I
Pregancy (patients of child-bearing age must be appropriately tested before chemotherapy),
LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease,
Prior systemic therapy
- Stratum II
Patients with progressive disease in risk organs,
Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations,
No written consent of the patient or his/her parents or legal guardian
- Stratum III
Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement,
Inadequate renal function as defined by serum creatinine > 3x normal for age
- Stratum IV
Pulmonary failure (requiring mechanical ventilation) not due to active LCH,
Isolated liver sclerosis or pulmonary fibrosis, without active LCH,
Uncontrolled active life-threatening infection.
Decreased renal function with a GFR of less than 50ml/1.73m2/min,
Pregnancy or active breast feeding,
Failure to provide signed informed consent
- Stratum V
Patients without any evidence of isolated tumorous CNS-LCH lesions or ND-CNS lesions
- Stratum VI
Patients with single-system LCH who have an isolated tumorous CNS lesion (eligible for Stratum V),
Patients with isolated CNS-risk or mfb lesion (eligible for Stratum I, Group 2)
- Stratum VII
no consent for long-term follow up available

Study & Design

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