NCT02205762Active, not recruitingPhase 2/3
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 May 2026
Brief summary (registry, in English)
Reduction of mortality in multi-system (ms)-LCH by early switch to salvage treatment of patients with risk organ involvement and without response to 1st-line therapy. Randomized investigation of prolongation or intensification of continuation therapy to reduce reactivations and late sequelae in ms-LCH. Randomized investigation to reduce reactivation rate, late sequelae by prolongation of continuation therapy (6 vs. 12 m) in single-system (ss)-LCH with isolated "CNS-Risk" lesion or multifocal bone (mfb) lesions. Investigation to achieve disease resolution, prevent reactivations, late sequelae in non-risk organ involvement patients with 2nd-line treatment (PRED/ARA-C//VCR) for 24 weeks followed by continuation therapy (Indomethacin vs. 6-MP/MTX) for 24 months in total.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1124 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 9 Oct 2024
- Lead sponsor
- St. Anna Childrens Cancer Research Institute GmbH
- Diseases
- Childhood cancers
- NCT number
- NCT02205762
- EU CT number
- 2024-512676-36-00
- EudraCT number
- 2011-001699-20
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1124
- 84 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy
Other
- Pregnancy
- Missing signed consent form
- LCH related permanent consequences
Who the study is looking for
- Histological verification of diagnosis of LCH
- Age < 18 years
- No prior systemic therapy
- Signed informded consent
- Met inclusion criteria for respective stratum
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (84)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Tirol Kliniken GmbH Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Paracelsus Medizinische Privatuniversitaet Salzburg Coordinator of this site? Confirm its status | Salzburg | Austria | Active, not recruiting |
| St. Anna Kinderspital GmbH Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Fakultni Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| Univerzita Karlova 2 Lekarska Fakulta Coordinator of this site? Confirm its status | Prague 5 | Czechia | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Active, not recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Active, not recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario HM Monteprincipe Coordinator of this site? Confirm its status | Boadilla del Monte | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| University Hospital Of Canary Islands Coordinator of this site? Confirm its status | San Cristobal De La Laguna | Spain | Active, not recruiting |
| Spanish Paediatric Clinical Trials Network Coordinator of this site? Confirm its status | Santiago De Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Nosokomeio Paidon I Agia Sofia Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Athens General Children's Hospital Panagioti And Aglaia Kyriakou Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Active, not recruiting |
| Mitera S.A. Coordinator of this site? Confirm its status | Marousi | Greece | Active, not recruiting |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Children's Health Ireland Coordinator of this site? Confirm its status | Dublin | Ireland | Active, not recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Active, not recruiting |
| Alma Mater Studiorum Universita Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Locale N. 8 Di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Second University Of Naples Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| ARNAS Civico Di Cristina Benfratelli Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Università degli Studi di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Active, not recruiting |
| Azienda Sanitaria Locale di Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Active, not recruiting |
| Universita' Degli Studi Di Roma La Sapienza Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Sanitaria Locale Di Taranto Coordinator of this site? Confirm its status | Taranto | Italy | Active, not recruiting |
| University of Trieste Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Active, not recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Active, not recruiting |
| Instytut Matki i Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Active, not recruiting |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Active, not recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.