Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
850
Countries
11
Sites
94
Histologically proven high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with sonic hedgehog (SHH) subgroup or non-SHH/non-wingless-type (WNT) (Groups 3 and 4) medulloblastoma, with at least one additional high risk feature
To evaluate whether the outcome in children, young people and adults with HR-MB is improved over standard therapy i.e. conventional (once a day) radiotherapy (RT) (standard therapy), for those treated with: hyperfractionated-accelerated radiotherapy (HART), or high-dose therapy (HDT) with thiotepa followed by conventio…
Key facts
- Sponsor
- The University Of Birmingham
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Nov 2021 → ongoing
- Decision date (initial)
- 2024-12-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Cancer Research UK · Deutsche Kinderkrebsstiftung · Swedish Childhood Cancerfond · Kom Op tegen kanker · AAMU Suomen Lasten Syöpäsäätiö · Danish Childhood Cancer Foundation · Steirische Kinderkrebshilfe
External identifiers
- EU CT number
- 2024-510578-25-00
- EudraCT number
- 2018-004250-17
- ISRCTN
- ISRCTN16314648
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate whether the outcome in children, young people and adults with HR-MB is improved over standard therapy i.e. conventional (once a day) radiotherapy (RT) (standard therapy), for those treated with: hyperfractionated-accelerated radiotherapy (HART), or high-dose therapy (HDT) with thiotepa followed by conventional RT.
To evaluate whether the outcome in HR-MB is different for those treated with two different maintenance chemotherapy therapies.
Secondary objectives 3
- To study the late effects of treatment and their impact on quality of survival (QoS), including neurocognitive function, neurological impairment, endocrine impairment, audiological function and secondary tumours
- To conduct comprehensive prospective biological studies in HR-MB, with the aims of (i) understanding the biological basis of HR-MB, (ii) identification and validation of diagnostic and prognostic biomarkers, and (iii) identification and validation of molecular targets with therapeutic potential and associated predictive biomarkers.
- To conduct prospective QoS, toxicity and pharmacogenomic studies with the aim of exploring clinical, host and tumour factors, and genetic variants, that relate to early and late side-effects of treatment and survival parameters
Conditions and MedDRA coding
Histologically proven high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with sonic hedgehog (SHH) subgroup or non-SHH/non-wingless-type (WNT) (Groups 3 and 4) medulloblastoma, with at least one additional high risk feature
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10027107 | Medulloblastoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Histologically proven (centrally reviewed) high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with SHH or non-SHH/non-WNT (Groups 3 and 4) medulloblastoma, with at least one of the following high risk features: Metastatic disease- Chang Stage M1, M2 and M3, Large cell/anaplastic MB (as defined by WHO criteria 2016 [1]), Patients with MYC or MYCN amplified tumours (unless MYCN amplified non-WNT/non-SHH Group 4 without any other high risk factors), Patients with somatic SHH-TP53 mutant tumours, Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and other biological risk factors (as above)
- Age at diagnosis ≥3 years. The date of diagnosis is the date on which initial surgery is undertaken
- Submission of biological material, including fresh frozen tumour samples and blood, in accordance with national and international schemes for molecular genetic assessment of biological markers, and for associated biological studies.
- No prior treatment for medulloblastoma, other than surgery, with the exception of one cycle of induction chemotherapy with carboplatin and etoposide may be given prior to trial entry and randomisation where there is clinical urgency to start treatment
- Adequate hepatic function defined as: Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age, unless the patient is known to have Gilbert’s syndrome OR ALT or AST < 2.5 X ULN for age
- Adequate renal function defined as creatinine < 1.5 x ULN
- Adequate haematological function defined as neutrophils ≥1 x 109/L; platelets ≥ 100 x 109/L, prior to induction chemotherapy
- No significant hearing deficit in at least one ear (significant hearing deficit defined as Chang grade 3 or above)
- Medically fit to receive treatment
- Documented negative pregnancy test for female patients of childbearing potential
- Patient agrees to use effective contraception whilst on treatment (patients of childbearing potential)
- Written informed consent from the patient and/or parent/legal guardian
- For Randomisation 2 ONLY: Patient entered into the SIOP-HRMB trial at diagnosis
- For Randomisation 2 ONLY: Patient treated with: Either Arm A (conventional radiotherapy) or Arm B (HART)
Exclusion criteria 12
- Patients with proven or with high likelihood of germline TP53, APC, PTCH1, SUFU, PALB2, BRCA2 gene alteration or any other DNA repair defect.
- Non-WNT/non-SHH Group 4 patients with MYCN amplification and no other high-risk factor
- Patients with CTNNB1 mutation positive WNT medulloblastoma irrespective of other risk factors
- Patients with significant residual tumour (> 1.5 cm2) following surgical resection of the primary tumour and no other biological risk factors
- Chang Stage M4 disease
- Brainstem or embryonal tumours in other sites
- Patients previously treated for a brain tumour or any type of malignant disease
- Medical contraindication to radiotherapy or chemotherapy
- Known hypersensitivity to any of the treatments or excipients
- Females who are pregnant or breastfeeding
- Patients who cannot be regularly followed up due to psychological, social, family, geographical or other issues
- Patients for whom non-compliance with treatment, management guidelines or monitoring is expected
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event-free survival
Secondary endpoints 2
- Overall survival
- Progression-free survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg/m2 milligram(s)/square meter
- Max total dose
- 24 mg/m2 milligram(s)/square meter
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11635848 · Product
- Active substance
- Lomustine
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY OF BIRMINGHAM
- Paediatric formulation
- No
- Orphan designation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- HARD CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10985MIG · Substance
- Active substance
- Thiotepa
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 1200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10985MIG · Substance
- Active substance
- Thiotepa
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 1200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 70 mg/m2 milligram(s)/square meter
- Max total dose
- 280 mg/m2 milligram(s)/square meter
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 1600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08567MIG · Substance
- Active substance
- Lomustine
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
The University Of Birmingham
- Sponsor organisation
- The University Of Birmingham
- Address
- Vincent Drive
- City
- Birmingham
- Postcode
- B15 2TT
- Country
- United Kingdom
Scientific contact point
- Organisation
- The University Of Birmingham
- Contact name
- Trial Coordinator
Public contact point
- Organisation
- The University Of Birmingham
- Contact name
- Trial Coordinator
Third parties 23
| Organisation | City, country | Duties |
|---|---|---|
| Proton Therapy Center Czech, s.r.o. ORL-000008306
|
180 00 Praha 8, Czechia | Other |
| Universitaetsklinikum Bonn AöR ORG-100009711
|
Bonn, Germany | Other |
| Masarykuv Onkologicky Ustav ORG-100029481
|
Brno-Stred, Czechia | Other |
| Great Ormond Street Hospital ORG-100008380
|
London, United Kingdom | Other |
| Sykehusapoteket Oslo ORL-000008603
|
Oslo, Norway | Other |
| University Of Southampton ORG-100010399
|
Southampton, United Kingdom | Other |
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
| Julius Clinical International B.V. ORG-100028683
|
Zeist, Netherlands | On site monitoring |
| St. Anna Kinderspital GmbH ORG-100023908
|
Vienna, Austria | Other |
| Masarykova Univerzita ORG-100021184
|
Brno, Czechia | Code 12 |
| Royal Victoria Infirmary ORG-100017117
|
Newcastle Upon Tyne, United Kingdom | Other |
| Aarhus Universitetshospital ORG-100047721
|
Aarhus N, Denmark | Other |
| Medical University Of Vienna ORG-100006190
|
Vienna, Austria | Other |
| Newcastle University Centre for Cancer ORL-000008337
|
Newcastle-upon-Tyne, United Kingdom | Other |
| Associazione Italiana Ematologia Oncologia Pediatrica ORG-100010651
|
Bologna, Italy | Code 5 |
| Universitaet Muenster ORG-100008258
|
Muenster, Germany | On site monitoring |
| Competence In Scientific Services Eggenreich & Gschanes GmbH ORG-100042988
|
Graz, Austria | On site monitoring |
| Universitaetsklinikum Augsburg ORG-100029226
|
Augsburg, Germany | Other |
| Vis Ethic Research S.r.l. ORG-100043098
|
Ferrara, Italy | On site monitoring, Code 9 |
| University Medical Center Hamburg-Eppendorf ORG-100008810
|
Hamburg, Germany | Other |
| QUARTET ORL-000008280
|
1200 Brussels, Belgium | Other |
| Alder Hey Children's Hospital ORG-100028395
|
Liverpool, United Kingdom | Other |
| Westdeutsches Protonentherapiezentrum Essen (WPE) gGmbH ORL-000008601
|
Essen, Germany | Other |
Locations
11 EU/EEA countries · 94 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 18 | 5 |
| Belgium | Ongoing, recruiting | 35 | 7 |
| Czechia | Authorised, recruiting | 24 | 2 |
| Denmark | Ongoing, recruiting | 12 | 3 |
| Finland | Ongoing, recruiting | 12 | 5 |
| Germany | Ongoing, recruiting | 147 | 48 |
| Italy | Ongoing, recruiting | 100 | 12 |
| Netherlands | Ongoing, recruiting | 29 | 2 |
| Norway | Ongoing, recruiting | 18 | 4 |
| Sweden | Ongoing, recruiting | 12 | 5 |
| United Kingdom | 0 | 1 | |
| Rest of world
Switzerland, United Kingdom
|
— | 443 | — |
Investigational sites
Medical University Of Vienna
Universitätsklinik für Kinder- und Jugendheilkunde, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University Of Graz
Univ.-Klinik für Kinder- und Jugendheilkunde, Neue Stiftingtalstrasse 6, 8010, Graz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitätsklinik für Kinder- und Jugendheilkunde, Muellner Hauptstrasse 48, 5020, Salzburg
Medizinische Universitaet Innsbruck
Department für Kinder- und Jugendheilkunde, Anichstrasse 35, 6020, Innsbruck
St. Anna Kinderspital GmbH
St. Anna Kinderspital, Kinderspitalgasse 6, Alsergrund, Vienna
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Pédiatrie hémato-oncologie, Jean Joseph Crocqlaan 15, 1020, Brussels
UZ Leuven
Kinderhemato-oncologie, Herestraat 49, 3000, Leuven
CHC MontLegia
Hémato - oncologie pédiatrique, Boulev. De Patience Et Beajonc 2, 4000, Liege
Cliniques Universitaires Saint-Luc
Hématologie et oncologie pédiatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Pediatrische hemato-oncologie, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Regional De La Citadelle
Hémato - oncologie pédiatrique, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Antwerp University Hospital
Kinderhemato-oncologie, Wilrijkstraat 10, 2650, Edegem
Fakultni Nemocnice V Motole
Klinika dětské onkologie, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Brno
Klinika dětské hematologie a onkologie, Jihlavska 340/20, Bohunice, Brno
Odense University Hospital
Hans Christian Andersen Children's Hospital, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of paediatric and adolescent medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus Universitetshospital
Department of paediatric and adolescent medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Pohjois-Pohjanmaan hyvinvointialue
Oulun yliopistollinen sairaala, Lasten ja nuorten tulosalue, Kajaanintie 50, 90220, Oulu
Pohjois-Savon hyvinvointialue
Kuopion yliopistollinen sairaala, Lasten veri- ja syöpätautien osasto, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
HUS-Yhtymae
HUS, Lasten ja nuorten sairaudet, lasten veri- ja syöpätaudit ja kantasolusiirrot, Stenbackinkatu 9, 00290, Helsinki
Varsinais-Suomen hyvinvointialue
Turun yliopistollinen sairaala, Lasten veri- ja syöpätaudit, Kiinamyllynkatu 4-8, 20520, Turku
Pirkanmaan hyvinvointialue
Tampereen yliopistollinen sairaala, Lasten veri- ja syöpätautien yksikkö, Elamanaukio 2, 33520, Tampere
Universitaetsklinikum Ulm AöR
Klinik für Kinder- und Jugendmedizin, Eythstrasse 24, Mitte, Ulm
Universitaetsklinikum Wuerzburg AöR
Päd. Onkologie und Hämatologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Universitaetsklinikum Mannheim GmbH
Päd. Hämatologie und Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Regensburg AöR
Päd. Hämatologie, Onkologie und Stammzelltransplantation, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Tuebingen AöR
Abt. I, Allgemeinpädiatrie, Hämatologie/Onkologie, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
HELIOS Kliniken Schwerin GmbH
Kinderonkologie/ Hämatologie, Wismarsche Strasse 393-397, 19049, Schwerin
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Zentrum für Kinder-, Jugend- und Frauenmedizin, Kriegsbergstrasse 62, Mitte, Stuttgart
Otto Von Guericke Universitaet Magdeburg
Päd. Hämatologie und Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaet Leipzig
Abteilung für Päd. Hämatologie, Onkologie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Kinderonkologisches Zentrum, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Schleswig-Holstein AöR
Pädiatrische Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Gemeinschaftsklinikum Mittelrhein gGmbH
Päd. Hämatologie und Onkologie, Koblenzer Str 115-155, 56073, Koblenz
Universitaetsklinikum Schleswig-Holstein AöR
Päd. Hämatologie und Onkologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Medical Center - University Of Freiburg
Klinik für Päd. Hämatologie und Onkologie, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
University Hospital Cologne AöR
Pädiatrische Hämatologie und Onkologie, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum Kassel GmbH
Klinik für Päd. Hämatologie und Onkologie, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Asklepios Klinik Sankt Augustin GmbH
Kinderonkologie, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Universitaetsklinikum Erlangen AöR
Pädiatrische Hämatologie und Onkologie, Loschgestrasse 15, Innenstadt, Erlangen
Universitaetsklinikum Giessen und Marburg GmbH
Päd. Hämatologie und Onkologie, Feulgenstrasse 10-12, 35392, Giessen
Universitaetsklinikum des Saarlandes AöR
Klinik für Päd. Onkologie und Hämatologie, Kirrberger Strasse 100, 66421, Homburg
Medizinische Hochschule Hannover
Klinik für Päd. Hämatologie und Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Kliniken der Stadt Koeln gGmbH
Kinderonkologie Station A5, Amsterdamer Strasse 59, Riehl, Cologne
Sana Kliniken Duisburg GmbH
Kinderklinik, Zu Den Rehwiesen 7-9, Wanheimerort, Duisburg
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Kinder- und Jugendmedizin, Schwanebecker Chaussee 50, Buch, Berlin
Universitaetsmedizin Greifswald KöR
Päd. Onkologie und Hämatologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Evangelisches Klinikum Bethel gGmbH
Hämatologie/Onkologie, Grenzweg 14, Gadderbaum, Bielefeld
Carl-Thiem-Klinikum Cottbus gGmbH
päd. Onkologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Staedtisches Klinikum Braunschweig gGmbH
Pädiatrische Hämatologie und Onkologie, Salzdahlumer Strasse 90, Suedstadt, Brunswick
University Medical Center Hamburg-Eppendorf
Klinik für Päd. Hämatologie und Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Muenster
Päd. Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Johannes Wesling Klinikum Minden
Eltern-Kind-Zentrum (ELKI), Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Klinikum der Universitaet Muenchen AöR
Abteilung für Hämatologie/Onkologie, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
HELIOS Klinikum Erfurt GmbH
Pädiatrische Hämatologie und Onkologie, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Gesundheit Nord gGmbH Klinikverbund Bremen
Eltern-Kind-Zentrum Prof. Hess Kinderonkologie, St.-Juergen-Strasse 1, Hulsberg, Bremen
Technische Universitaet Dresden
Klinik und Poliklinik für Kinder-und Jugendmedizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden
HELIOS Klinikum Krefeld GmbH
Hämatologie und Onkologie, Lutherplatz 40, Diessem/lehmheide, Krefeld
Klinikum Dortmund gGmbH
Kinderonkologisches Zentrum, Beurhausstrasse 40, Mitte, Dortmund
Universitaetsmedizin Goettingen
Päd. Onkologie und Hämatologie, Robert-Koch-Strasse 42, Weende, Goettingen
Martin-Luther-Universitaet Halle-Wittenberg
Klinik und Poliklinik für Kinder- und Jugendmedizin, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Jena KöR
Hämatologie, Onkologie und Stammzelltransplantation, Am Klinikum 1, Lobeda, Jena
Charite Universitaetsmedizin Berlin KöR
Klinik für Pädiatrie mit Schwerpunkt Onkologie/Hämatologie, Augustenburger Platz 1, Wedding, Berlin
Goethe University Frankfurt
Zentrum für Kinder- und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Staedtisches Klinikum Karlsruhe gGmbH
Onkologie und Hämatologie, Moltkestrasse 90, Weststadt, Karlsruhe
Gemeinschaftskrankenhaus Herdecke gGmbH
Kinder- und Jugendmedizin, Gerhard-Kienle-Weg 4, Westende, Herdecke
Universitaetsklinikum Essen AöR
Klinik für Kinderheilkunde III, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Augsburg
Schwäbisches Kinderkrebszentrum, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Bonn AöR
Päd. Hämatologie und Onkologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Heidelberg AöR
Kinderheilkunde III, Im Neuenheimer Feld 430, Neuenheim, Heidelberg
University Hospital Consorziale Policlinico
Hospital Pediatrics with oncohematological address, Piazza Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera di Padova
U.O.C. (Complex Operating Unit) Pediatric Oncohematology, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. (Complex structure) Pediatric Oncohematology and Transplant Center, Piazza Polonia 94, 10126, Turin
ARNAS G. Brotzu
Pediatric Oncohematology, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Ospedaliera Universitaria Integrata Verona
U.O.C. (Complex operating unit) Pediatric Oncohematology and Transplant Center, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
S.S.D. (Simple departmental structure) of pediatric oncohematology, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
U.O.C. (Complex operating unit) of Pediatric Hemato-Oncology and Bone Marrow Transplant, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Pediatric Oncohematology, Via Filippo Corridoni 11, 60123, Ancona
IRCCS Istituto Giannina Gaslini
UOS (Simple Departmental Operational Unit) at the Department of Hemato-Oncology, Via Gerolamo Gaslini 5, 16147, Genoa
Ospedale Pediatrico Bambino Gesu
Department of Oncology-Pediatric Hematology and Transfusion Medicine, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Ospedaliera Santobono Pausilipon
Department of oncohematology, Via Posillipo 226, 80123, Naples
Azienda Sanitaria Universitaria Friuli Centrale
Maternal and child Department - Pediatric clinic, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Prinses Maxima Centrum voor Kinderoncologie B.V.
Neuro-oncology, Heidelberglaan 25, 3584 CS, Utrecht
Universitair Medisch Centrum Groningen
Radiation Oncology, Hanzeplein 1, 9713 GZ, Groningen
Universitetssykehuset Nord-Norge HF
Pediatric hematology and oncology, Sykehusvegen 38, 9019, Tromsoe
Haukeland Universitetssykehus
Pediatric hematology and oncology, Jonas Lies vei 65, Department of Oncology, Bergen
Oslo University Hospital HF
Pediatric hematology and oncology, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Pediatric hematology and oncology, Ragnhilds Gate 15, 7030, Trondheim
University Hospital
Crown Princess Victoria Children´s Hospital, University Hospital, 58185, Linköping
Uppsala University Hospital
Pediatric hematology and oncology, Akademiska Sjukhuset Ingang 86 B16, Pet Centrum, Uppsala
Queen Silvia Children's Hospital
Queen Silvia Children`s Hospital, Queen Silvia Children`s Hospital, Sahlgrenska University Hospital, Gothenburg
Astrid Lindgren Children´s Hospital, Karolinska University Hospital
Astrid Lindgrens Childrens Hospital, Eugeniavägen 23, 17176, Stockholm
Norrlands Universitetssjukhus
Department of Pediatric Oncology and Hematology, Children and Youth Center, Norrlands Universitetssjukhus Umeå, 901 85, Umeå
University Hospital
Children´s Cancer Center, Skåne University Hospital, 221 85, Lund
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 | 2021-11-05 | 2024-08-22 | |||
| Belgium | 2022-12-06 | 2023-03-31 | |||
| Czechia | 2024-03-08 | ||||
| Denmark | 2022-03-25 | 2022-03-30 | |||
| Finland | 2024-02-07 | 2024-08-08 | |||
| Germany | 2023-08-01 | 2024-01-17 | |||
| Italy | 2022-03-24 | 2022-09-15 | |||
| Netherlands | 2022-04-22 | 2022-10-10 | |||
| Norway | 2022-09-07 | 2023-02-15 | |||
| Sweden | 2023-04-27 | 2023-11-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 175 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_Public | 3.0 |
| Recruitment arrangements (for publication) | CTIS Template Blank Document V1 20 May 2024 | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 12-16 1st R_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 12-16 2nd R_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 12-16 Screening_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 16ao 1stR_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 16ao 2ndR_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_children aged 16ao screening_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_parents-caregivers 1stR_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_parents-caregivers 2ndR_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_parents-caregivers screening_NL_NL_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_Child 8-11y BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_entry_R1 12-14y_ CZ_ CS_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_entry_R1 15-17y_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_entry_R1 18Plus_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_entry_R1 parent_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_pregnancy monitoring_ CZ_ CS_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_R2 12y 14y_ CZ_ CS_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_R2 15-17y_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_R2 18 plus_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_R2 Parent_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_Screening 12-14y_ CZ_ CS_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_screening 15-17y_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_screening 18y_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_ HRMB_screening parents_ CZ_ CS_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Child 8-11y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Child 8-11y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 12-17y_BE_ EN_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 12-17y_BE_ FR_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 12-17y_BE_ NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 18y_BE_ EN_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 18y_BE_ FR_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 Child 18y_BE_ NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 parent_BE_ EN_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 parent_BE_ FR_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_entry_R1 parent_BE_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 12-17y_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 12-17y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 12-17y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 18y_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 18y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 18y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 parents_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 parents_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_R2 parents_BE_EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 12-17y_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 12-17y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 12-17y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 18y_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 18y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 18y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 8-11y_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 8-11y_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening 8-11y_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening parents_BE_ EN_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening parents_BE_ FR_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS_and_ICF_HRMB_Screening parents_BE_ NL_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_SIOP HRMB ICF Kontaktdatenblatt_AT_ DE_Public | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_BiobANK 16Y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_BiobANK Parent_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_entry_R1 15-17y_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_R2 15-17y_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_R2 18 plus_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ HRMB_R2 Parent_DK_DA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Einschluss R1 Eltern Master_AT_ DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Einschluss R1 Erwachsene Master_AT_ DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Einschluss R1 Jugendliche 14 17J Master_AT_ DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Einschluss R1 R2 Kinder 8 13J Master clean_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Entry and R1 15-18y_SE_SV_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Entry and R1 7-14y_SE_SV_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB 12-14 Years subject R2 Information and consent FI_FI_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent 18 Years Optional tasks in the future studies FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent for 15-17 Years Processing Personal Data FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent of subject aged 1214 RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent of subject aged 1517 RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent of subject aged 18 RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent of subject under 12 RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent Parent Guardian Optional tasks in the future studies FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Consent Parent Guardian RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Eligibility Screening Adults Consent_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Eligibility Screening Parent-Guardian Consent_ IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Eligibility Screening Parent-Guardian information_ IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information 15 years Guardian RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information 15-17 years RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information 18 years RESEARCH SUITABILITY ASSESSMENT FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information 18 years Trial Entry and R1 FI_FI_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB information and consent of subjects under 12 years of age R2 FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information for 15-17 years Trial Entry and R1 FI_FI_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information for Guardian Optional tasks in the future studies FI_FI_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information for Subjects 18 Optional tasks in the future studies FI_FI_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information guardian Trial Entry and R1 FI_FI_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information on pregnancy monitoring for subject FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Information on pregnancy monitoring for subject partner FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Parent Guardian Information 15 years for R2 FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Parent Guardian Trial Entry and R1 Consent FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Pregnancy Monitoring Consent of subject partner FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Consent 15-17 years FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Consent 18 years FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Consent Parent Guardian FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Information 15-17 years FI_FI_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Information 18 years FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB R2 Notification to the guardian of a 15-17-years FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Study suitability Notification to the guardian of a 15-17-year FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Subjects consent Pregnancy monitoring FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Trial Entry and R1 Consent 15-17-years FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Trial Entry and R1 Consent 18 years FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Trial Entry and R1 Consent of subject aged 1214 FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Trial Entry and R1 Consent of subject under 12 FI_FI_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB Trial Entry and R1 Notification to the guardian of a 15-17-year FI_FI_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_BiobANK 12-15Y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_BiobANK 7-11Y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_entry_R1 parent_DK_DA_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_PatInfo 12-15y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_PatInfo 16y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_PatInfo 7-11y_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_PatInfo KLIK_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_PatInfo parent_DE_DE_Public | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_Screening Privacy Parent-Guardian_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_Trial Entry and Randomisation 1 Parent-Guardian Consent_IT_IT_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_HRMB_Trial Entry_R1_DK_DA_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Information letter 18 years and parents_NO_NO_Public | 1.8 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Information letter children under 12_NO_NO_Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Information letter youth 12-18 years_NO_NO_Public | 1.7 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Information sheet for pregnancy and childbirth with a partner_NO_NO_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Information sheet for pregnancy_NO_NO_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Informationsblatt St Anna Arm C Eltern_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Informationsblatt St Anna Arm C Patienten_AT_ DE_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Informationsblatt WPE Eltern_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Informationsblatt WPE Patienten_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Monitoring Schwangerschaf_AT_ DE_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_R2 Eltern Master_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_R2 Erwachsene Master_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_R2 for 7-14y_SE_SV_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_R2 for guardians and 15-18y_SE_SV_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_R2 Jugendliche Master_AT_ DE_Public | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Referenzdiagnostik Eltern Master_AT_ DE_Public | 5 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Referenzdiagnostik Erwachsene Master_AT_ DE_Public | 5 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Screening parents and 15-18y_SE_SV_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Eligibility Screening 11-17 information_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Eligibility Screening Adults Consent_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Randomization 2 11-17_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Randomization 2 Consent of adults_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Randomization 2 information adults_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Randomization 2 information parent-guardian_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB Randomization 2 Parent-Guardian Consent_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_ Randomisation 2 privacy adults_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_ Randomisation 2 privacy parent-guardian_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Screening Privacy adults_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 11-17_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 Adults Consent_IT_IT_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 adults information_IT_IT_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 Parent-Guardian information_IT_IT_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 privacy adult_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_SIOP HRMB_Trial Entry and Randomisation 1 privacy parent and guardian_IT_IT_Public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_children aged 12-16_maintenance chemo arm C_NL_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_children aged 16ao_maintenance chemo arm C_NL_NL_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_parents-caregivers_maintenance chemo arm C_NL_NL_Public | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Lomustine 10mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Lomustine_40mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lomustine_40mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E3_SmPC_Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E4_SmPC_Cyclophosphamide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E4_SmPC_Temozolomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E5_SmPC_Vincristine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E6_SmPC_Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E7_SmPC_Thiotepa | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Netherlands | Acceptable 2024-11-06
|
2024-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-15 | Netherlands | Acceptable with conditions 2025-10-31
|
2025-10-31 |