Clinical trial • Oncology

CARBOPLATIN for Medulloblastoma (SHH-activated; TP53 wild-type; non-MYC-amplified), newly diagnosed non-metastatic

Clinical trial of CARBOPLATIN for Medulloblastoma (SHH-activated; TP53 wild-type; non-MYC-amplified), newly diagnosed non-metastatic.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Medulloblastoma (SHH-activated; TP53 wild-type; non-MYC-amplified), newly diagnosed non-metastatic
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
30-04-2025
First CTIS Authorization Date
26-08-2025

Trial design

Randomised, two randomized interventional arms: arm a: "head start" 4 regimen; arm b: hitskk regimen (named standard regimens). specific drug doses/schedules for the arms are not specified in the provided summary.-controlled trial across 43 sites in Denmark, France, Germany and others.

Randomised
Yes
Comparator
Two randomized interventional arms: Arm A: "Head Start" 4 regimen; Arm B: HITSKK regimen (named standard regimens). Specific drug doses/schedules for the arms are not specified in the provided summary.
Biomarker Stratified
True, biomarkers: SHH-activation status; TP53 wild-type; non-MYC-amplified
Target Sample Size
46
Trial Duration For Participant
1825

Eligibility

Recruits 46 paediatric patients.

Vulnerable Population
Participants are young children (Age at diagnosis < 5 years) and considered a vulnerable population. Consent must be provided by parents/legal representatives: "Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures". Parents/legal representatives must be able and willing to participate for the duration of the study. No separate child assent procedure is specified in the provided criteria.

Inclusion criteria

  • {"criterion_text":"- Age at diagnosis < 5 years"}
  • {"criterion_text":"- Patients with institutional suspicion or diagnosis of SHH-activated MB"}
  • {"criterion_text":"- Patient and family in social circumstances that will allow neuropsychological follow-up"}
  • {"criterion_text":"- Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures"}
  • {"criterion_text":"- Patient and the parents/legal representatives are able and willing to participate in the entire study (if patient is eligible)"}

Exclusion criteria

  • {"criterion_text":"- Patient previously treated for a brain tumor or any type of malignant disease"}
  • {"criterion_text":"- Patients, in whom compliance with toxicity management guidelines and study procedures cannot be assured"}
  • {"criterion_text":"- History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of an investigational medicinal product"}
  • {"criterion_text":"- Patients/parents who do not wish to abstain from treatment with live vaccines during study participation"}
  • {"criterion_text":"- Patients with a language barrier too extensive to complete neuropsychological tests based on the investigator’s judgment"}
  • {"criterion_text":"- Patients with severe premorbid developmental delay (based on the investigator’s judgment), which will not allow WPPSI-IV assessment after 2.5 years"}
  • {"criterion_text":"- Patients that cannot undergo MRI"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Full-Scale Intelligence Quotient (IQ) as measured by the Wechsler Pre-school and Primary Scale of Intelligence (WPPSI-IV) administered to those between the ages of 2 years and 6 months to 7 years and 7 months old at 2.5 years after diagnosis (+/- 6 months)","definition_or_measurement_approach":"Measured using WPPSI-IV administered to children aged 2 years 6 months to 7 years 7 months at 2.5 years after diagnosis (+/- 6 months)."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS): time from diagnosis to first re-lapse, first disease progression or death, whichever occurs first. Censored at the time of last contact in patients without event","definition_or_measurement_approach":"Time-to-event endpoint measured from diagnosis to first relapse, progression or death; censoring at last contact if no event."}
  • {"endpoint_text":"- Survival free of radiotherapy and progression (rtPFS): Time from diagnosis to first radiotherapy, first relapse, first disease progression or death, whatever is first. Censored at last contact in patients without event","definition_or_measurement_approach":"Time-to-event measure from diagnosis to first radiotherapy, relapse, progression or death; censoring at last contact if no event."}
  • {"endpoint_text":"- Overall survival (OS): time from diagnosis to death due to any cause. Censored at the time of last contact in alive patients","definition_or_measurement_approach":"Time from diagnosis to death from any cause; censoring at last contact for survivors."}
  • {"endpoint_text":"- Time to first second malignancy: time from diagnosis to first second malignancy. Death for other reasons will be used as competing event. A second malignancy is any malignant tumor disease defined by the International Classification of Childhood Cancer (ICCC)-3. Benign diseases except ICCC-3 included CNS-tumors are not being considered","definition_or_measurement_approach":"Time-to-event with competing risk (death for other reasons); second malignancy defined per ICCC-3."}
  • {"endpoint_text":"- Toxicity will be defined according to CTCAE Version 5.0","definition_or_measurement_approach":"Adverse events/toxicities graded per CTCAE v5.0."}
  • {"endpoint_text":"- Time to death due to toxicity: time from diagnosis to death related to therapy (as defined by investigator assessment). In order to describe the toxic death rate for the regimens under investigation, deaths occurring in patients after relapse are excluded, even if they occur due to toxicity from relapse therapy. Deaths from reasons other than toxicity will be used as a competing event","definition_or_measurement_approach":"Investigator-assessed treatment-related death; competing events accounted for; excludes deaths after relapse."}
  • {"endpoint_text":"- WPPSI-IV on therapy (all children >2.5 years at diagnosis), and WISC-V at 5 years after diagnosis (+/- 12 months range allowed; WPPSI-IV if younger than 6;0 years)","definition_or_measurement_approach":"Neurocognitive testing using WPPSI-IV during therapy and WISC-V at 5 years post-diagnosis (age-dependent instrument selection); ±12 months window for 5-year assessment."}
  • {"endpoint_text":"- Subdomain-specific neurocognitive outcome parameters from WPPSI-IV and WISC-V (primary index scales): Verbal Comprehension Index (all children ≥ 2.5 years old), Visual Spatial Index (all children ≥ 2.5 years old), Fluid Reasoning Index (all children ≥ 4.0 years old), Working Memory Index (all children ≥ 2.5 years old), Processing Speed Index (all children 4 years and older)","definition_or_measurement_approach":"Specific WPPSI-IV/WISC-V index scores measured according to age eligibility for each index."}
  • {"endpoint_text":"- Subdomain-specific neurocognitive outcome parameters from Beery Visual Motor Integration (VMI) Test (all children ≥ 2.0 years old)","definition_or_measurement_approach":"Beery VMI test scores for children aged ≥2.0 years."}
  • {"endpoint_text":"- Subdomain-specific neurocognitive outcome parameters from Purdue Pegboard Test (all children ≥ 5.0 years old)","definition_or_measurement_approach":"Purdue Pegboard Test outcomes for children aged ≥5.0 years."}
  • {"endpoint_text":"- Development and Adaptive Functioning: Adaptive Behavior Assessment System (ABAS, versions II or 3) at diagnosis, 2.5- and 5 years after diagnosis","definition_or_measurement_approach":"Adaptive behavior measured by ABAS II or III at specified timepoints."}
  • {"endpoint_text":"- Quality of Life (QoL): - PedsQL Infant Scale or PedsQL 4.0 parent-report measure at diagnosis, followed by PedsQL 4.0 and PedsQL Fatigue Scale at 2.5 and 5 years after diagnosis by Parent- and Self-report","definition_or_measurement_approach":"QoL assessed by age-appropriate PedsQL instruments; parent- and self-report as applicable at specified timepoints."}
  • {"endpoint_text":"- Quality of Life (QoL): - BRIEF-P or BRIEF or BRIEF 2 parent-report measure based on age at 2.5 and 5 years after diagnosis by Parent-report","definition_or_measurement_approach":"Executive function/behavior assessed by BRIEF-P/BRIEF/BRIEF2 parent-report by age at specified timepoints."}
  • {"endpoint_text":"- Quality of Life (QoL): Strengths and Difficulties Questionnaire (SDQ) parent-report at 2.5 and 5 years after diagnosis","definition_or_measurement_approach":"Behavioral screening by SDQ parent-report at 2.5 and 5 years."}
  • {"endpoint_text":"- Longitudinal development of neurocognitive, QoL and behavioral outcomes to evaluate potential change over time, change in: ABAS (II or 3) between diagnosis, 2.5 years and 5 years","definition_or_measurement_approach":"Longitudinal change in ABAS scores between baseline, 2.5y and 5y."}
  • {"endpoint_text":"- Longitudinal development of neurocognitive, QoL and behavioral outcomes to evaluate potential change over time, change in: WPPSI-IV (including subtests) between baseline and 2.5 years and WISC-V (including subtests) at 5 years","definition_or_measurement_approach":"Longitudinal change in WPPSI-IV and WISC-V (age-appropriate) including subtests across timepoints."}
  • {"endpoint_text":"- Longitudinal development of neurocognitive, QoL and behavioral outcomes to evaluate potential change over time, change in: PedsQL between diagnosis, 2.5 years and 5 years after diagnosis","definition_or_measurement_approach":"Longitudinal PedsQL change between specified timepoints."}
  • {"endpoint_text":"- Longitudinal development of neurocognitive, QoL and behavioral outcomes to evaluate potential change over time, change in: BRIEF-P or BRIEF or BRIEF-2 between 2.5 years and 5 years after diagnosis","definition_or_measurement_approach":"Change in BRIEF measures between 2.5 and 5 years."}
  • {"endpoint_text":"- Longitudinal development of neurocognitive, QoL and behavioral outcomes to evaluate potential change over time, change in: SDQ between 2.5 years and 5 years after diagnosis","definition_or_measurement_approach":"Change in SDQ between 2.5 and 5 years."}
  • {"endpoint_text":"- Ototoxicity: Hearing evaluation according to SIOP Boston Scales and Chang-Scale 2.5 years and 5 years after diagnosis (patients with normal Distortion-Product Otoacoustic Emissions (DPOAE) will be considered as not having hearing loss)","definition_or_measurement_approach":"Hearing assessed by SIOP Boston and Chang scales at 2.5 and 5 years; DPOAE normal = no hearing loss."}
  • {"endpoint_text":"- Leukoencephalopathy: modified Fazekas scale: 2.5 and 5 years after diagnosis","definition_or_measurement_approach":"MRI-based leukoencephalopathy assessment using modified Fazekas scale at 2.5 and 5 years."}
  • {"endpoint_text":"- To compare PFS, rtPFS, OS between epigenetically defined subtypes of SHH-MB as defined by classification based on the Heidelberg brain tumor classifier Version 11 (or higher): Independent variable = subtyp, dependent variables : PFS, rtPFS, and OS","definition_or_measurement_approach":"Exploratory comparison of survival endpoints across Heidelberg classifier epigenetic subtypes."}
  • {"endpoint_text":"- Rate of patients with genetically confirmed basal cell nevus syndrome (BCNS, Gorlin-Syndrome, OMIM: 109400): Defined by central sequencing of relevant genes from germline material","definition_or_measurement_approach":"Proportion of patients with germline-confirmed BCNS determined by central sequencing."}

Recruitment

Planned Sample Size
46
Recruitment Window Months
128
Consent Approach
Informed consent is provided by parents/legal representatives. Inclusion criteria require: "Ability of parents/legal representatives to understand the patient information and to personally sign and date the informed consent to participate in screening procedures" and that parents/legal representatives are able and willing to participate in the entire study. Country-specific parent information and informed consent forms are provided (documents available in English, French, German, Dutch and Danish in the CTIS document list). No separate child assent procedure is specified in the provided documents.

Geography

Total Number Of Sites
43
Total Number Of Participants
46

Denmark

Earliest CTIS Part Ii Submission Date
15-08-2025
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
11
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Rigshospitalet
Department Name
Department of Paediatric and Adolescent Medicine
Principal Investigator Name
Astrid Sehested
Principal Investigator Email
astrid.marie.sehested@regionh.dk
Contact Person Name
Astrid Sehested
Site Name
Odense University Hospital
Department Name
The Hans Christian Andersen Childrens Hospital
Principal Investigator Name
Sine Lykkedegn
Principal Investigator Email
sine.lykkedegn@rsyd.dk
Contact Person Name
Sine Lykkedegn
Contact Person Email
sine.lykkedegn@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Paediatric and Adolescent Medicine
Principal Investigator Name
Torben Stamm Mikkelsen
Principal Investigator Email
torben.mikkelsen@clin.au.dk
Contact Person Name
Torben Stamm Mikkelsen
Contact Person Email
torben.mikkelsen@clin.au.dk

France

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
41
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Institut Gustave Roussy
Department Name
Children and adolescent oncology department
Principal Investigator Name
Christelle Dufour
Principal Investigator Email
Christelle.DUFOUR@gustaveroussy.fr
Contact Person Name
Christelle Dufour

Germany

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
42
Number Of Sites
32
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Klinik für Kinder- und Jugendmedizin I, Sektion für Kinderonkologie und hämatologie
Principal Investigator Name
Christiane Heydrich-Karsten
Principal Investigator Email
christiane.heydrich-karsten@uksh.de
Contact Person Name
Christiane Heydrich-Karsten
Site Name
Universitaetsklinikum Essen AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Stephan Tippelt
Principal Investigator Email
Stephan.Tippelt@uk-essen.de
Contact Person Name
Stephan Tippelt
Contact Person Email
Stephan.Tippelt@uk-essen.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Kinderheilkunde I, Allgemeinpädiatrie, Hämatologie und Onkologie
Principal Investigator Name
Thomas Eichholz
Principal Investigator Email
Thomas.eichholz@med.uni-tuebingen.de
Contact Person Name
Thomas Eichholz
Site Name
Klinikum Dortmund gGmbH
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Marco Westkemper
Principal Investigator Email
marco.westkemper@klinikumdo.de
Contact Person Name
Marco Westkemper
Contact Person Email
marco.westkemper@klinikumdo.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Päd. Hämatologie und Onkologie
Principal Investigator Name
Stefan Rutkowski
Principal Investigator Email
s.rutkowski@uke.de
Contact Person Name
Stefan Rutkowski
Contact Person Email
s.rutkowski@uke.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
Principal Investigator Name
Claudia Blattmann
Principal Investigator Email
c.blattmann@klinikum-stuttgart.de
Contact Person Name
Claudia Blattmann
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Klinik und Poliklinik für Pädiatrie I
Principal Investigator Name
Caspar Kühnöl
Principal Investigator Email
caspar.kuehnoel@uk-halle.de
Contact Person Name
Caspar Kühnöl
Contact Person Email
caspar.kuehnoel@uk-halle.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Kinder- und Jugendklinik
Principal Investigator Name
Martin Chada
Principal Investigator Email
martin.chada@uk-erlangen.de
Contact Person Name
Martin Chada
Contact Person Email
martin.chada@uk-erlangen.de
Site Name
Medizinische Hochschule Hannover
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Alexander Claviez
Principal Investigator Email
claviez.alexander@mh-hannover.de
Contact Person Name
Alexander Claviez
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Alfred Leipold
Principal Investigator Email
alfred.leipold@klinikum-karlsruhe.de
Contact Person Name
Alfred Leipold
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Päd. Onkologie, Hämatologie und Hämostaseologie
Principal Investigator Name
Jörg Faber
Principal Investigator Email
joerg.faber@unimedizin-mainz.de
Contact Person Name
Jörg Faber
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Klinik für Kinder und Jugendmedizin Abt. Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Thorsten Langer
Principal Investigator Email
thorsten.langer@uksh.de
Contact Person Name
Thorsten Langer
Contact Person Email
thorsten.langer@uksh.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Norbert Jorch
Principal Investigator Email
Norbert.Jorch@evkb.de
Contact Person Name
Norbert Jorch
Contact Person Email
Norbert.Jorch@evkb.de
Site Name
Johannes Wesling Klinikum Minden
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Bernhard Erdlenbruch
Contact Person Name
Bernhard Erdlenbruch
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Päd. Hämatologie, Onkologie und SZT
Principal Investigator Name
Udo Kontny
Principal Investigator Email
ukontny@ukaachen.de
Contact Person Name
Udo Kontny
Contact Person Email
ukontny@ukaachen.de
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Kinderkrankenhaus
Principal Investigator Name
Meinolf Siepermann
Principal Investigator Email
siepermannm@kliniken-koeln.de
Contact Person Name
Meinolf Siepermann
Contact Person Email
siepermannm@kliniken-koeln.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Zentrum für Kinder- und Jugendmedizin
Principal Investigator Name
Gabriele Calaminus
Principal Investigator Email
gabriele.calaminus@ukbonn.de
Contact Person Name
Gabriele Calaminus
Contact Person Email
gabriele.calaminus@ukbonn.de
Site Name
HELIOS Klinikum Krefeld GmbH
Department Name
Zentrum für Kinder- und Jugendmedizin, Abt. für Hämatologie und Onkologie
Principal Investigator Name
Susanne Eisert
Principal Investigator Email
susanne.eisert@helios-gesundheit.de
Contact Person Name
Susanne Eisert
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Cornelis van Tilburg
Principal Investigator Email
cornelis.vantilburg@med.uni-heidelberg.de
Contact Person Name
Cornelis van Tilburg
Site Name
Universitaet Leipzig
Department Name
Department für Frauen- und Kindermedizin
Principal Investigator Name
Caspar Kühnöl
Principal Investigator Email
caspar.kuehnoel@uk-halle.de
Contact Person Name
Caspar Kühnöl
Contact Person Email
caspar.kuehnoel@uk-halle.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Päd. Hämatologie und Onkologie
Principal Investigator Name
Christof Kramm
Principal Investigator Email
Christof.kramm@meduni-goettingen.de
Contact Person Name
Christof Kramm
Site Name
Sana Kliniken Duisburg GmbH
Department Name
Abt. für Hämatologie und Onkologie
Principal Investigator Name
Tanja Höll
Principal Investigator Email
tanja.hoell@sana.de
Contact Person Name
Tanja Höll
Contact Person Email
tanja.hoell@sana.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Abteilung für Päd. Hämatologie, Onkologie, Stammzelltransplantation
Principal Investigator Name
Marcus Jakob
Principal Investigator Email
Marcus.Jakob@ukr.de
Contact Person Name
Marcus Jakob
Contact Person Email
Marcus.Jakob@ukr.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
Principal Investigator Name
Florian Babor
Principal Investigator Email
florian.babor@med.uni-duesseldorf.de
Contact Person Name
Florian Babor
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Paediatric Haematology and Oncology
Principal Investigator Name
Miriam van Buiren
Principal Investigator Email
miriam.buiren@uniklinik-freiburg.de
Contact Person Name
Miriam van Buiren
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Hämatologie/ Onkologie
Principal Investigator Name
Patrick Hundsdörfer
Principal Investigator Email
patrick.hundsdoerfer@helios-gesundheit.de
Contact Person Name
Patrick Hundsdörfer
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen
Principal Investigator Name
Michaela Nathrath
Principal Investigator Email
michaela.nathrath@gnh.net
Contact Person Name
Michaela Nathrath
Contact Person Email
michaela.nathrath@gnh.net
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Michael Frühwald
Principal Investigator Email
michael.fruehwald@uk-augsburg.de
Contact Person Name
Michael Frühwald
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Kinder- und Jugendliche
Principal Investigator Name
Lisa Nonnenmacher
Principal Investigator Email
lisa.nonnenmacher@uniklinik-ulm.de
Contact Person Name
Lisa Nonnenmacher
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Klinik für Kinder und Jugendmedizin
Principal Investigator Name
Axel Sauerbrey
Principal Investigator Email
axel.sauerbrey@helios-gesundheit.de
Contact Person Name
Axel Sauerbrey
Site Name
University Hospital Cologne AöR
Department Name
Pädiatrische Onkologie und Hämatologie
Principal Investigator Name
Thorsten Simon
Principal Investigator Email
thorsten.simon@uk-koeln.de
Contact Person Name
Thorsten Simon
Contact Person Email
thorsten.simon@uk-koeln.de
Site Name
Rostock University Medical Center
Department Name
Kinder- und Jugendklinik
Principal Investigator Name
Carl-Friedrich Classen
Principal Investigator Email
carl-friedrich.classen@med.uni-rostock.de
Contact Person Name
Carl-Friedrich Classen

Belgium

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
32
Number Of Sites
6
Number Of Participants
2

Sites

Site Name
University Childrens Hospital Queen Fabiola
Department Name
Hématologie et oncologie pédiatrique
Principal Investigator Name
Pierluigi Calò
Principal Investigator Email
pierluigi.calo@hubruxelles.be
Contact Person Name
Pierluigi Calò
Contact Person Email
pierluigi.calo@hubruxelles.be
Site Name
UZ Leuven
Department Name
Paediatric Haematology-Oncology and Stern Cell Transplantation
Principal Investigator Name
Sandra Jacobs
Principal Investigator Email
sandra2.jacobs@uzleuven.be
Contact Person Name
Sandra Jacobs
Contact Person Email
sandra2.jacobs@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric Hemato-Oncology & Stem Cell Transplant
Principal Investigator Name
Leen Willems
Principal Investigator Email
leen.willems@uzgent.be
Contact Person Name
Leen Willems
Contact Person Email
leen.willems@uzgent.be
Site Name
CHC MontLegia
Department Name
Pediatric hemato-oncology
Principal Investigator Name
Christophe Chantrain
Principal Investigator Email
christophe.chantrain@chc.be
Contact Person Name
Christophe Chantrain
Contact Person Email
christophe.chantrain@chc.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric Haematology and Oncology
Principal Investigator Name
An Van Damme
Principal Investigator Email
an.vandamme@saintluc.uclouvain.be
Contact Person Name
An Van Damme
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pediatric Hematology Oncology
Principal Investigator Name
Joris Verlooy
Principal Investigator Email
joris.verlooy@uza.be
Contact Person Name
Joris Verlooy
Contact Person Email
joris.verlooy@uza.be

Netherlands

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
164
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Neurooncology
Principal Investigator Name
Sabine Plasschaert
Contact Person Name
Sabine Plasschaert

Sponsor

Primary sponsor

Full Name
GPOH gGmbH
Organisation Type
Patient organisation/association
Country Of Registered Address
Germany

Contract research organisations

Name
Paediatrisches Forschungsnetzwerk gGmbH
Responsibilities
sponsorDuties codes: 1,12,8,9
Name
Zentrum fuer Forschungsfoerderung in der Paediatrie GmbH
Responsibilities
sponsorDuties codes: 1,12,8,9

Third parties

  • {"country":"Germany","full_name":"Paediatrisches Forschungsnetzwerk gGmbH","duties_or_roles":"sponsorDuties codes: 1,12,8,9","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Zentrum fuer Forschungsfoerderung in der Paediatrie GmbH","duties_or_roles":"sponsorDuties codes: 1,12,8,9","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"University Medical Center Hamburg-Eppendorf","duties_or_roles":"sponsorDuties codes: 11,13,15 (Study Centre),5,6","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
200 mg/ml
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
65 mg/kg
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
150 mg/m2
Investigational Product Name
THIOTEPA
Active Substance
THIOTEPA
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
10 mg/kg
Investigational Product Name
METHOTREXATE (intravenous/intrathecal formulations)
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS / INTRAVENTRICULAR
Route
INTRAVENOUS / INTRAVENTRICULAR
Maximum Dose
400 mg/kg (as listed for one formulation) / 2 mg (intrathecal formulation listed as max daily 2 mg)
Investigational Product Name
VINCRISTINE
Active Substance
VINCRISTINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
1.5 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
3.5 mg/kg
Combination Treatment
Yes

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