Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
2,030
Countries
12
Sites
84
Langerhans Cell Histiocytosis
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 inves…
Key facts
- Sponsor
- St. Anna Childrens Cancer Research Institute GmbH
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 9 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512676-36-00
- EudraCT number
- 2011-001699-20
- ClinicalTrials.gov
- NCT02205762
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Therapy, Efficacy
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.
Secondary objectives 3
- To validate prospectively a new scoring system for disease activity and treatment response assessment.
- To investigate the cumulative incidence of radiographic and clinical neurodegeneration in patients with "CNS-Risk" bone lesions and endocrine deficits.
- To study the natural history of LCH in patients not needing upfront systemic therapy and the long-term consequences and quality of life of all registered (with and without systemic therapy) patients.
Conditions and MedDRA coding
Langerhans Cell Histiocytosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Regulatory references
- Scientific advice from competent authorities
- Bundesministerium Fuer Soziales Gesundheit Pflege Und Konsumentenschutz
- Plan to share IPD
- No
- IPD plan description
- De-identified individual clinical trial data will not be shared with anybody.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histological verification of diagnosis of LCH
- Age < 18 years
- No prior systemic therapy
- Signed informded consent
- Met inclusion criteria for respective stratum
Exclusion criteria 4
- Pregnancy
- Prior systemic therapy
- Missing signed consent form
- LCH related permanent consequences
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Reactivation-free survival
- Overall and disease free survival
- To study the course of neurodegenerative CNS-LCH
- Response of isolated tumorous CNS lesions to 2-CdA
- Rate and spectrum of permanent consequences
Secondary endpoints 4
- Incidence of permanent consequences
- Toxicity of treatment
- Proportion fo patients alive and free of disease without permanent consequences
- Cumulative incidence of reactivations in risk organs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
Melphalan 50 mg Powder and Solvent for Solution for Injection/Infusion
PRD981281 · Product
- Active substance
- Melphalan
- Substance synonyms
- MELFALAN, L-SARCOLYSINE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 140 mg/m2 milligram(s)/square meter
- Max total dose
- 140 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA03 — MELPHALAN
- Marketing authorisation
- PL 39699/ 0039
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cytarabine 20 mg/ml Solution for Injection/Infusion
PRD7370525 · Product
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 9750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- PA2315/082/002
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD992060 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 8070 mg/m2 milligram(s)/square meter
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- A07EA01 — PREDNISOLONE
- Marketing authorisation
- PL 29831/0178
- MA holder
- WOCKHARDT UK LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4925112 · Product
- Active substance
- Indometacin Ph. Eur.
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 1120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 80 Week(s)
- Authorisation status
- Authorised
- ATC code
- M01AB01 — INDOMETACIN
- Marketing authorisation
- PL 0142/0112
- MA holder
- ACTAVIS UK LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4260858 · Product
- Active substance
- Methotrexate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg/m2 milligram(s)/square meter
- Max total dose
- 1600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 80 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA01 — METHOTREXATE
- Marketing authorisation
- PA2315/062/002
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vinblastine Sulfate 1 mg/ml Solution for Injection or Infusion
PRD1178000 · Product
- Active substance
- Vinblastine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 6 mg/m2 milligram(s)/square meter
- Max total dose
- 258 mg/m2 milligram(s)/square meter
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CA01 — VINBLASTINE
- Marketing authorisation
- PA 0822/208/001
- MA holder
- PFIZER HEALTHCARE IRELAND
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD1794901 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 150 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PA 2315/035/001
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LITAK 2 mg/ml solution for injection
PRD718231 · Product
- Active substance
- Cladribine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 9 mg/m2 milligram(s)/square meter
- Max total dose
- 150 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BB04 — CLADRIBINE
- Marketing authorisation
- EU/1/04/275/002
- MA holder
- LIPOMED GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mercaptopurine Silver Pharma 50 mg tablets
PRD9044063 · Product
- Active substance
- Mercaptopurine Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 33950 mg/m2 milligram(s)/square meter
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BB02 — MERCAPTOPURINE
- Marketing authorisation
- PA23137/001/001
- MA holder
- SILVER PHARMA S.L.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LEMTRADA 12 mg concentrate for solution for infusion
PRD3337642 · Product
- Active substance
- Alemtuzumab
- Substance synonyms
- CAMPATH-1H, CAMPATH-1
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.2 mg/Kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AG06 — -
- Marketing authorisation
- EU/1/13/869/001
- MA holder
- SANOFI BELGIUM
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OCTAGAM 10 %, Lösung zur intravenösen Infusion
PRD313308 · Product
- Active substance
- Human Normal Immunoglobulin (IV)
- Substance synonyms
- HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION, HUMAN NORMAL IMMUNOGLOBULIN (IVIG)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 500 mg/kg milligram(s)/kilogram
- Max total dose
- 6000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- PEI.H.03627.01.1
- MA holder
- OCTAPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Anna Childrens Cancer Research Institute GmbH
- Sponsor organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Address
- Zimmermannplatz 10, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Contact name
- Milen Minkov, MD, PhD
Public contact point
- Organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Contact name
- Milen Minkov, MD, PhD
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Coronis Research S.A. ORG-100028085
|
Chalandri, Greece | Code 5 |
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
12 EU/EEA countries · 84 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 66 | 5 |
| Belgium | Ongoing, recruitment ended | 90 | 2 |
| Czechia | Ongoing, recruitment ended | 45 | 2 |
| Denmark | Ongoing, recruitment ended | 56 | 4 |
| Greece | Ongoing, recruitment ended | 13 | 6 |
| Ireland | Ongoing, recruitment ended | 5 | 1 |
| Italy | Ongoing, recruitment ended | 422 | 25 |
| Netherlands | Ongoing, recruitment ended | 113 | 1 |
| Norway | Ongoing, recruitment ended | 35 | 4 |
| Poland | Ongoing, recruitment ended | 47 | 1 |
| Spain | Ongoing, recruitment ended | 170 | 27 |
| Sweden | Ongoing, recruitment ended | 62 | 6 |
| Rest of world
Belarus, United Kingdom, Korea, Republic of, Russian Federation, Australia, United States, Brazil, Switzerland, Canada, Serbia, New Zealand
|
— | 906 | — |
Investigational sites
Paracelsus Medizinische Privatuniversitaet Salzburg
Department of Pediatric Hematology/Oncology, Strubergasse 21, 5020, Salzburg
University Hospital Graz
Department of Pediatric Hematology/Oncology, Auenbruggerplatz 9, 8036, Graz
Kepler Universitaetsklinikum GmbH
Department of Pediatric Hematology/Oncology, Krankenhausstrasse 26-30, 4020, Linz
St. Anna Kinderspital GmbH
Deptartment of Pediatric Hematology/Oncology, Kinderspitalgasse 6, Alsergrund, Vienna
Tirol Kliniken GmbH
Department of Pediatric Hematology/Oncology, Anichstrasse 35, 6020, Innsbruck
Universitair Ziekenhuis Gent
Department Paediatric Haemato-oncology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Department Paediatric Haemato-oncology, Herestraat 49, 3000, Leuven
Fakultni Nemocnice Brno
Dept. of Pediatric Oncology, Obilni Trh 526/11, Veveri, Brno-Stred
Univerzita Karlova 2 Lekarska Fakulta
Pediatric Hematology/Oncology, V Uvalu 84/1, 150 06, Prague 5
Aalborg University Hospital
Dept. of Paediatric Haematology & Oncology, Reberbansgade 15, 9000, Aalborg
Aarhus Universitetshospital
Dept. of Pediatric and Adolescent Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Dept. of Pediatrics and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Hans Christian Andersen Children´s Hospital, J B Winsloews Vej 4, 5000, Odense C
Nosokomeio Paidon I Agia Sofia
Department of Pediatric Hematology and Oncology (TAO), Thivon, Papadiamantopoulou, Athens
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Oncology Department Aglaia Kyriakou (OTAK), Thivon And Leivadias, Ampelokipoi, Athens
University General Hospital Of Heraklion
Hematology-Oncology Children’s Clinic, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Thessaloniki Ahepa
Paediatric and Adolescent Hematology Oncology Unit of B' Paediatric Clinic of Aristotle University, 1st St Kiriakidis Str, 546 36, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
Pediatric-Oncology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Mitera S.A.
Children's - Adolescent's Oncology Clinic, Erythrou Stavrou Str 6, 151 23, Marousi
Azienda Ospedaliera di Padova
Dipartimento di Pediatria Università di Padova Cattedra Di Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova
Istituto Nazionale Dei Tumori
S.C. Oncologia Pediatrica, Via Giacomo Venezian 1, 20133, Milan
Fondazione IRCCS San Gerardo Dei Tintori
Clinica Pediatrica dell’Università Milano – Bicocca A.O. San Gerardo – Fondazione MBBM, Via Giovanni Battista Pergolesi 33, 20900, Monza
IRCCS Istituto Giannina Gaslini
Dipartimento di Scienze Pediatriche Generali e Specialistiche U.O.C. Oncologia, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Oncoematologia Ped. e Centro Trapianti, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Parma
U.O. di Pediatria e Oncoematologia Pediatrica Az. Osp. Di Parma Ospedali Riuniti, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero Universitaria Di Modena
Dipartimento Materno-Infantile, Largo Del Pozzo 71, 41124, Modena
Alma Mater Studiorum Universita Di Bologna
Oncologia Ematologia Pediatrica Ist. "Lalla Seràgnoli", Via Giuseppe Massarenti 9, 40138, Bologna
University Of Trieste
U.O. Emato-Oncologia Pediatrica Università degli studi di Trieste, Via Dell' Istria 65, 34137, Trieste
Azienda Ospedaliera Universitaria Integrata Verona
U.O.C Oncoematologia Pediatrica, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
ARNAS Civico Di Cristina Benfratelli
Oncoematologia Pediatrica ARNAS Civico Ospedale dei Bambini G. di Cristina, Piazza Nicola Leotta 4, 90127, Palermo
Second University Of Naples
Servizio di Oncologia Pediatrica Dipartimento di Pediatria, Piazza Luigi Miraglia 2, 80138, Naples
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Dipartimento di Oncologia A.O. Santobono – Pausilipon, Via Posillipo 226, 80123, Naples
Universita' Degli Studi Di Roma La Sapienza
Oncoematologia pediatrica Ospedale “Bambino Gesù", Viale Del Policlinico 155, 00161, Rome
Azienda Sanitaria Locale Di Pescara
Dipartimento di Ematologia Ospedale Civile Pescara, Via Renato Paolini 47, 65124, Pescara
Azienda Sanitaria Locale Di Taranto
U.O.C. di Pediatria ed Oncoematologia Pediatrica Ospedale Santissima Annunziata, Via Bruno, 72100, Taranto
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Gobbi, Via Filippo Corridoni 11, 60123, Ancona
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Clinica Pediatrica Oncoematologia pediatrica e TMO, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
U.O Pediatria Ospedale Infermi, Viale Luigi Settembrini 2, 47923, Rimini
Universita' Degli Studi Di Perugia
S.C. di Oncoematologia Pediatrica con Trapianto di CSE,, Strada Di Sant Andrea Delle Fratte, 06132, Perugia
Azienda Ospedaliera Universitaria Meyer IRCCS
Dipartimento A.I. Oncoematologia SODC Tumori ped.ci pianto di cellule staminali Azienda Osp, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliero Universitaria Pisana
Pediatric Hematology and Oncology, Via Roma 67, 56126, Pisa
Fondazione IRCCS Policlinico San Matteo
UOC Oncoematologia Pediatrica Dipartimento Salute della Donna e del Bambino, Viale Camillo Golgi 19, 27100, Pavia
University Hospital Consorziale Policlinico
Dipartimento Biomedicina Età Evolutiva, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Oncoematologia Pediatrica e Patologia della Coagulazione, Via Edward Jenner 18, 09121, Cagliari
Prinses Maxima Centrum voor Kinderoncologie B.V.
Hemato-Oncology, Heidelberglaan 25, 3584 CS, Utrecht
Helse Bergen HF
Pediatric Hematology/Oncology, Haukelandsveien 22, 5021, Bergen
St. Olavs Hospital HF
Department Paediatric Haemato-oncology, Prinsesse Kristinas G. 3, 7030, Trondheim
Universitetssykehuset Nord-Norge HF
Pediatric Hematology/Oncology, P. O. Box 100, 9038, Tromsoe
Oslo University Hospital HF
Dept. of Pediatric Medicine, Sognsvannsveien 20, 0372, Oslo
Instytut Matki I Dziecka
Dept. of Oncology and Surgical Oncology f. children and Youth, Ul Marcina Kasprzaka 17 A, 01-211, Warsaw
Hospital Universitario Donostia
Servicio de Oncología y Hematología Pediátricas, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Reina Sofia
Servicio de Oncología y Hematología Pediátricas, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Hm Monteprincipe
Servicio de Oncología y Hematología Pediátricas, Avenida De Monteprincipe 25, 28660, Boadilla Del Monte
Hospital Universitario De Badajoz
Servicio de Oncología y Hematología Pediátricas, Avenida Elvas S/n, 06006, Badajoz
University Hospital Of Canary Islands
Servicio de Oncología y Hematología Pediátricas, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Hospital General Universitario De Albacete
Servicio de Oncología y Hematología Pediátricas, Calle Hermanos Falco 37, 02006, Albacete
Hospital Universitario De Navarra
Servicio de Oncología y Hematología Pediátricas, Irunlarrea Kalea 3, 31008, Pamplona
Hospital De La Santa Creu I Sant Pau
Servicio de Oncología y Hematología Pediátricas, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Virgen De Las Nieves
Servicio de Oncología y Hematología Pediátricas, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Clinico Universitario De Valladolid
Servicio de Oncología y Hematología Pediátricas, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Alvaro Cunqueiro
Servicio de Oncología y Hematología Pediátricas, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario Central De Asturias
Servicio de Oncología y Hematología Pediátricas, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Regional De Malaga
Aula de Hematología Servicio de Hematología, Avenida De Carlos De Haya S/N, 29010, Malaga
University Clinical Hospital Virgen De La Arrixaca
Oncohematologia infantil, Carretera Madrid Cartagena Sn, El Palmar, Murcia
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Servicio de Oncología y Hematología Pediátricas, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Infantil Universitario Nino Jesus
Servicio de Oncología y Hematología Pediátricas, Avenida Menendez Pelayo 65, 28009, Madrid
Spanish Paediatric Clinical Trials Network
Servicio de Oncología y Hematología Pediátricas, Travesia Da Choupana S/n, 15706, Santiago De Compostela
Hospital General Universitario Gregorio Maranon
Servicio de Oncología y Hematología Pediátricas, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Unviersitario Miguel Servet
Servicio de Oncología y Hematología Pediátricas, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario 12 De Octubre
Servicio de Oncología y Hematología Pediátricas, Bloque D, Avenida De Cordoba Sn, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Oncología y Hematología Pediátricas, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Dr. Balmis
Servicio de Oncología y Hematología Pediátricas, Avinguda Del Pintor Baeza 12, 03010, Alicante
Sant Joan De Deu Barcelona Hospital
Servicio de Oncología y Hematología Pediátricas, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario De Cruces
Servicio de Oncología y Hematología Pediátricas, Cruces Plaza S/n, 48903, Barakaldo
University Hospital Son Espases
Servicio de Oncología y Hematología Pediátricas, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Y Politecnico La Fe
Servicio de Oncología y Hematología Pediátricas, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Servicio de Oncología y Hematología Pediátricas, Paseo De La Castellana 261, 28046, Madrid
Karolinska University Hospital
Pediatric oncology center, Astrid Lindgren Children's hospital, Eugeniavägen 23,17164 Stockholm, Eugeniavagen 3, 171 64, Solna
Region Vaesterbotten
Pediatric Oncology center, Norrlands university hospital, 90185 Umeå, Umea University, 901 85, Umea
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Pediatric oncology center, Behandlingsvägen 7, Behandlingsvagen 7, Harlanda, Gothenburg
Region Oestergoetland
Pediatric Oncology center, H.K.H. Kronprinsessan Victoria Children's hospital,Linköping University H, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Skane Skanes Universitetssjukhus
Pediatric Oncology center, Ward 64, Lasarettsgatan 48, Lund, Entregatan 7, 222 42, Lund
Uppsala University Hospital
Pediatric Oncology and hematology center, Akademiska Sjukhuset, Uppsala, Akademiska Sjukhuset, 751 85, Uppsala
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-10-14 | 2024-10-14 | 2025-11-30 | ||
| Belgium | 2024-10-09 | 2024-10-09 | 2025-11-30 | ||
| Czechia | 2024-10-11 | 2024-10-11 | 2025-11-30 | ||
| Denmark | 2024-10-10 | 2024-10-10 | 2025-11-30 | ||
| Greece | 2024-10-11 | 2024-10-11 | 2025-11-30 | ||
| Ireland | 2024-10-09 | 2024-10-09 | 2025-11-30 | ||
| Italy | 2024-10-14 | 2024-10-14 | 2025-11-30 | ||
| Netherlands | 2024-10-14 | 2024-10-14 | 2025-11-30 | ||
| Norway | 2024-10-09 | 2024-10-09 | 2025-11-30 | ||
| Poland | 2024-10-13 | 2024-10-13 | 2025-11-30 | ||
| Spain | 2024-10-14 | 2024-10-14 | 2025-11-30 | ||
| Sweden | 2024-10-11 | 2024-10-11 | 2025-11-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 430 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-512676-36-00_GR_redacted | 1.7 |
| Protocol (for publication) | D1_Protocol 2024-512676-36-00_redacted | 1.7 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material placeholder | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 1_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 1_7-13 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 1_parents_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 2_ 7-13 y_redacted | 1.7 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 2_14-18 y_redacted | 1.7 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str I_Group 2_parents_redacted | 1.7 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str II_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str II_7-13 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str II_parents_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str III_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str III_7-13 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str III_parents_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str IV_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str IV_7-13 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str IV_parents_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str V_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str V_7-13 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str V_parents_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str VI_14-18 y_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str VI_7-13 y_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Str VI_parents_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF LCH privacy redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Strata I II III V VI 10-13 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 1 Genitori redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 1 pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 1 pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 2 Genitori redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 2 pz 14-17 yr redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO I Gruppo 2 pz 7-13 yr redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO II Genitori redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO II Pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO II Pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO III Genitori yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO III pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO III pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO IV Genitori redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO IV Pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO IV Pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO V Genitori redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO V Pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO V Pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO VI Genitori redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO VI Pz 14-17 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF STRATO VI Pz 7-13 yr redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 7-13 yr redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 1 volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 14-17 yr Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 7-13 yr redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 Parent Guardian Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum I Group 2 volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II 7-13 yr redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum II volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III 7-13 yr redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum III volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV 10-13 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV 14-17 Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Bone Marrow Donor 10-13 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Bone Marrow Donor 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Bone Marrow Donor Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Lymphocyte Donor 10-13 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Lymphocyte Donor 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Lymphocyte Donor Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum IV Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V 7-13 yr redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum V volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI 14-17 yr Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI 14-18 yr redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI 7-13 yr redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI Eltern redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI Parent Guardian Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Stratum VI volljahrige Pat_neu redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Contact list AT redacted | 1.8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_S III_amended IRL_REDACTED | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV Assent_SI G2_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S III_amended IRL_REDACTED | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S IV_BM_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S IV_Cells_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S IV_DLI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Parents_SI G2_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S III_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S IV_BM_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S IV_Cells_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S IV_DLI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV ICF Patients_16plus_SI G2_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV main 15-17yr redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV main adults redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV main parents redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16 yrs_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16 yrs_S III_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16 yrs_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16yrs_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16yrs_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 13-16yrs_SI G2_amended IRL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S III_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIs and ICF LCH-IV PIS 16plus_S IV_BM_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S IV_Cells_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S IV_DLI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 16plus_SI G2_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12 yrs_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12 yrs_S III_amended IRL_REDACTED | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12 yrs_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12 yrs_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12yrs_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS 7-12yrs_SI G2_amended IRL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Donor undr16_S IV_BM_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Donor undr16_S IV_Cells_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S II_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S III_amended IRL_REDACTED | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S IV_BM_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S IV_Cells_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S IV_DLI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S V_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_S VI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_SI G1_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Parents_SI G2_amended IRL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS Patient undr16_S IV_DLI_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV PIS undr16_S IV_amended IRL_REDACTED | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 1 15-17yr redacted | n.a |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 1 adults redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 1 parents redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 3 15-17yr redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 3 adults redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 3 parents redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 4 15-17yr redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 4 adults redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 4 parents redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 5 15-17yr redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF LCH-IV trial 5 adults redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICf LCH-IV trial 5 parents redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 1 forldre redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 1 voksne redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 3 forldre redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 3 voksne redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 4 forldre redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 4 voksne redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 5 forldre redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV forsg 5 voksne redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV generelt forldre redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Samtykke LCH-IV generelt voksne redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_1 NY Stratum 1 Gruppe 1 barn 12-16ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_1 NY Stratum 1_Gruppe 1 foreldre_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_1 NY Stratum 1_Gruppe 1 ungdom 16-18ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_1 NY Stratum1_Gruppe 1 barn under 12ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_2 NO Stratum 1_Gruppe 2 barn 12-16ar_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_2 NO Stratum 1_Gruppe 2 barn under 12ar_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_2 NO Stratum 1_Gruppe 2 ungdom 16-18ar_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_1_2 NO Stratum1_Gruppe 2 foreldre_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2 NY Stratum 2 barn 12-16ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2 NY Stratum 2 barn under 12ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2 NY Stratum 2 foreldre_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2 NY Stratum 2 ungdom 16-18ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_3 NY Stratum 3 barn under 12ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_3 NY Stratum 3 barn12-16ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_3 NY Stratum 3 foreldre_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_3 NY Stratum 3 ungdom 16-18ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_5 NY Stratum 5 barn 12-16ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_5 NY Stratum 5 barn under 12ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_5 NY Stratum 5 foreldre_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_5 NY Stratum 5 ungdom 16-18ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6 NY Stratum 6 barn 12-16ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6 NY Stratum 6 barn under 12ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6 NY Stratum 6 foreldre_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_6 NY Stratum 6 ungdom 16-18ar_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 1 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 1 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 1 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 1 rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 2 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 2 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 2 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum I skup 2 rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum II 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum II 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum II 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum II rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum III 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum III 15-17 let | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum III 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum III 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum III rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum IV 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum IV 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum IV 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum IV rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum V 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum V 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum V 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum V rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum VI 12-14 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum VI 15-17 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum VI 18 let_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_LCH-IV IP-IS Stratum VI rodice_redacted | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 1_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 1_8-11 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 1_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 1_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 2_12-17 ans_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 2_8-11 ans_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 2_parents_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau I groupe 2_plus de 18 ans_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau II_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau II_8-11 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau II_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau II_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau III_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau III_8-11 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau III_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau III_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV Niveau IV_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV Niveau IV_8-11 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau IV_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau IV_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau V_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau V_8-11 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau V_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau V_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau VI_12-17 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau VI_8-11ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau VI_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau VI_plus de 18 ans | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV niveau VI_plus de 18 ans_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 1_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_12-17 jaar_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_12-17 year_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_8-11 jaar_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_8-11 year_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_ouders_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_over18 years_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_parents_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum I group 2_plus 18 jaar_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum II_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum III_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum IV_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum V_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_12-17 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_12-17 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_8-11 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_8-11 year_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_ouders_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_over18 years_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_parents_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCH-IV stratum VI_plus 18 jaar_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr1 jongeren va16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr1 kinderen 12-15jr_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr1 ouders_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr2 jongeren va16jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr2 kinderen 12-15jr_REDACTED | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrI Gr2 ouders_REDACTED | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrII jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrII kinderen 12-15jr_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrII ouders_REDACTED | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIII jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIII kinderen 12-15jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIII ouders_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIV jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIV kinderen 12-15jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrIV ouders_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV1 jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV1 kinderen 12-15jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV1 ouders_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV2 jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV2 kinderen 12-15jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrV2 ouders_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrVI jongeren va 16jr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrVI kinderen 12-15jr_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_LCHIV_PIFIC StrVI ouders_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G1 over 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G1 represent legal_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G1 under 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G2_legal representative_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G2_over 12 yr_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I G2_under 12 yr_REDACTED | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 1_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 1_7-13yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 1_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 2_14-18yr_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 2_7-13yr_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum I_group 2_parents_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II over 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II represent legal_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II under 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II_7-13yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum II_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III over 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III represent legal_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III under 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III_7-13yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum III_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV adults_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV over 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV represent legal_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV under 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum IV_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V over 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V represent legal_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V under 12 yr_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V_7-13yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum V_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum VI_14-18yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum VI_7-13yr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Stratum VI_parents_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_TC_SIS and ICF Contact list AT | 1.8 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Placeholder | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Indometacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Mercaptopurine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Methotrexate | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Vinblastine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC 2-CDA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Alemtuzumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cytarabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fludarabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Immunglobuline | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Melphalan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-27 | Austria | Acceptable 2024-10-09
|
2024-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-17 | Acceptable | 2026-05-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-17 | Austria | Acceptable | 2026-05-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-27 | Acceptable | 2026-04-14 |