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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (84)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Graz
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GrazAustriaActive, not recruiting
Tirol Kliniken GmbH
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InnsbruckAustriaActive, not recruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaActive, not recruiting
Paracelsus Medizinische Privatuniversitaet Salzburg
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SalzburgAustriaActive, not recruiting
St. Anna Kinderspital GmbH
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ViennaAustriaActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Fakultni Nemocnice Brno
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Brno-StredCzechiaActive, not recruiting
Univerzita Karlova 2 Lekarska Fakulta
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Prague 5CzechiaActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Hospital General Universitario de Albacete
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AlbaceteSpainActive, not recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital Universitario de Badajoz
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BadajozSpainActive, not recruiting
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario HM Monteprincipe
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Boadilla del MonteSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
University Hospital Of Canary Islands
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San Cristobal De La LagunaSpainActive, not recruiting
Spanish Paediatric Clinical Trials Network
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Santiago De CompostelaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainActive, not recruiting
Hospital Alvaro Cunqueiro
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VigoSpainActive, not recruiting
Hospital Unviersitario Miguel Servet
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ZaragozaSpainActive, not recruiting
Nosokomeio Paidon I Agia Sofia
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AthensGreeceActive, not recruiting
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
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AthensGreeceActive, not recruiting
University General Hospital of Heraklion
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HeraklionGreeceActive, not recruiting
Mitera S.A.
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MarousiGreeceActive, not recruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceActive, not recruiting
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceActive, not recruiting
Children's Health Ireland
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DublinIrelandActive, not recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
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AnconaItalyActive, not recruiting
University Hospital Consorziale Policlinico
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BariItalyActive, not recruiting
Alma Mater Studiorum Universita Di Bologna
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
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CagliariItalyActive, not recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyActive, not recruiting
IRCCS Istituto Giannina Gaslini
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GenoaItalyActive, not recruiting
Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
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NaplesItalyActive, not recruiting
Second University Of Naples
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NaplesItalyActive, not recruiting
Azienda Ospedaliera di Padova
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PadovaItalyActive, not recruiting
ARNAS Civico Di Cristina Benfratelli
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PalermoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Università degli Studi di Perugia
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PerugiaItalyActive, not recruiting
Azienda Sanitaria Locale di Pescara
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PescaraItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Unita Sanitaria Locale Della Romagna
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RiminiItalyActive, not recruiting
Universita' Degli Studi Di Roma La Sapienza
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RomeItalyActive, not recruiting
Azienda Sanitaria Locale Di Taranto
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TarantoItalyActive, not recruiting
University of Trieste
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TriesteItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
Prinses Maxima Centrum voor Kinderoncologie B.V.
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UtrechtNetherlandsActive, not recruiting
Helse Bergen HF
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BergenNorwayActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayActive, not recruiting
St. Olavs hospital HF
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TrondheimNorwayActive, not recruiting
Instytut Matki i Dziecka
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WarsawPolandActive, not recruiting
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
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GothenburgSwedenActive, not recruiting
Region Oestergoetland
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LinkopingSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
Region Vaesterbotten
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UmeaSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.