INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR CHILDREN AND ADOLESCENTS WITH LANGERHANS CELL HISTIOCYTOSIS
Phase 3
Recruiting
- Conditions
- Langerhans cell histiocytosis1001886510027655
- Registration Number
- NL-OMON50201
- Lead Sponsor
- Stichting Kinderoncologie Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 85
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
Exclusion Criteria
Exclusion criteria are stratum specific
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints are different for the different strata, therefore listed<br /><br>per stratum here.<br /><br>Stratum I & II: Reactivation- free survival<br /><br>Stratum III: The response will be evaluated at 4-5 weeks from the initiation of<br /><br>the second cycle (about 9-10 weeks from start of Stratum III).<br /><br>Stratum IV: To determine the overall and disease free survival at 1 and 3 years<br /><br>after reduced intensity conditioning hematopoietic stem cell transplantation<br /><br>(RIC-HSCT)<br /><br>Stratum V: To study the course of ND-CNS-LCH (both radiological and clinical<br /><br>neurodegeneration) * To study the impact of 2-CdA on the response of isolated<br /><br>tumorous CNS lesions.<br /><br>Stratum VI: Reactivation-free survival<br /><br>Stratum VII: Cumulative incidence of specific permanent consequences (PC) e.g.<br /><br>diabetes insipidus (DI), growth hormone deficiency (GHD), neuropsychological<br /><br>impairment</p><br>
- Secondary Outcome Measures
Name Time Method