Clinical trial • Not applicable • Oncology

LOMUSTINE for Medulloblastoma

Not applicable trial of LOMUSTINE for Medulloblastoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Medulloblastoma
Trial Stage
Not applicable
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
28-08-2024
First CTIS Authorization Date
26-09-2024

Trial design

Randomised, sr arm: radiotherapy (23.4 gy neuraxis irradiation plus boost to primary tumour) without carboplatin versus radiotherapy with carboplatin concomitantly (followed by modified maintenance chemotherapy). lr and wnt-hr arms: neuraxis irradiation plus boost and reduced-intensity chemotherapy (not described as randomized); shh-tp53 arm: treatment adapted to tp53 mutation status compared to a historic mb shh tp53-mutant cohort (historic comparator).-controlled Not applicable trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
SR arm: radiotherapy (23.4 Gy neuraxis irradiation plus boost to primary tumour) without carboplatin versus radiotherapy with carboplatin concomitantly (followed by modified maintenance chemotherapy). LR and WNT-HR arms: neuraxis irradiation plus boost and reduced-intensity chemotherapy (not described as randomized); SHH-TP53 arm: treatment adapted to TP53 mutation status compared to a historic MB SHH TP53-mutant cohort (historic comparator).
Real World Control
True, SHH-TP53 arm compares outcomes to a historic MB SHH TP53mut cohort (historic/real-world comparator).
Biomarker Stratified
True, biomarkers: WNT activation (β-catenin mutation) for LR/WNT-HR; SHH activation and TP53 mutation for SHH-TP53; genetic subgroup status (WNT/SHH/group 3/group 4) used in subgroup allocation.
Target Sample Size
41

Eligibility

Recruits 41 paediatric patients.

Pregnancy Exclusion
All arms: Patients who are pregnant
Vulnerable Population
Study includes children and adolescents. "All arms: Written informed consent (and patient assent where appropriate) for therapy according to the laws of each participating country." Age-specific information and consent/assent handling is documented: there are numerous age- and country-specific subject information and informed consent forms for parents, children and adolescents (e.g. L1_SIS and ICF files for children, juveniles, parents in multiple country versions). Parental consent and patient assent are required as appropriate by local law.

Inclusion criteria

  • {"criterion_text":"- LR: Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 16 years\n- SR: WNT-subgroup negativity\n- SR: For patients with SHH activated tumours: exclusion of germline alteration of TP53, PTCH and SUFU is required, and recommended for BRCA2 and PALB2. Exclusion of somatic mutation is sufficient for enrolment of the patient. In case of somatic alteration, urgent diagnostic evaluation for germline alteration after appropriate consent is necessary\n- LR: Histologically proven and genetically defined medulloblastoma including the following subgroups, as defined in the WHO classification (2016): medulloblastoma, WNT-activated Histologic subtype: medulloblastoma, classic or medulloblastoma, desmoplastic/nodular; Pre-treatment central pathology review, as well as central molecular confirmation of WNT-activation is considered mandatory\n- WNT-HR, SHH-TP53: Age at diagnosis, at least 3–5 years (depending on the country)\n- WNT-HR: Histologically proven and genetically defined medulloblastoma including the following subgroups, as defined in the WHO classification (2016): medulloblastoma, WNT-activated; Histologic subtype: classic medulloblastoma, desmoplastic/nodular medulloblastoma, large-cell/anaplastic medulloblastoma\n- LR, SR: Clinically standard -risk medulloblastoma\n- All arms: Submission of high quality biological material including fresh frozen tumour samples and blood for the molecular assessment of biological markers (such as the assessment of MYC gene copy number status) in national biological reference centersSubmission of CSF is recommended\n- LR: No amplification of MYC or MYCN (determined by FISH or aCGH)\n- LR: Low-risk biological profile, defined as presence of β-catenin mutation (mandatory testing) resulting in WNT activation\n- LR, SR, WNT-HR: No prior therapy for medulloblastoma other than surgery\n- LR-, SR-, WNT-HR-arm: No significant sensineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing no impairement ≥ 20 dB at 1-3 kHz (best ear). If performance of pure tone audiometry is not possible postoperatively, normal otoacoustic emissions are acceptable, if there is no history for hearing deficit\n- All arms: Postoperative therapy aiming to start no more than 28 days after surgery. Foreseeable inability to start therapy within 40 days after surgery renders patients ineligible for the study\n- All arms: CTC grades < 2 for liver, renal, haematological function\n- WNT-HR: Low-risk biological profile, defined as WNT-subgroup positivity\n- WNT-HR: Clinical high risk features\n- SHH-TP53: Histologically proven medulloblastoma, genetically defined as SHH-activated TP53 mutant, as defined in the WHO classification (2016)\n- SHH-TP53: Patients can be included irrespective of histological subtype of medulloblastoma (inclusion of AMB, DMB, CMB, LCMB and MBEN allowed) and irrespective of evidence of MYC/MYCN amplification (inclusion if MYC/MYCN amplification is absent or present)\n- SHH-TP53: Complete postoperative staging investigations according to PNET 5 MB – standards (pre- and postoperative MRI, spinal MRI, cytospin of lumbar CSF with sufficient quality and central review where applicable) is required; patients are eligible irrespective of staging result, i.e. with or without residual tumor, and localized or metastatic disease\n- SHH-TP53: Evaluation of germline TP53 status is required before start of irradiation. Patients with germline TP53 mutation, TP53 mosaicism and/ or somatic TP53 mutation are eligible.\n- SHH-TP53: Diagnosis of SHH-activated TP53-mutant medulloblastoma as first or secondary malignancy\n- LR-, SR-, WNT-HR-arm: No identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration (evaluation of PALB2 and BRCA2 not mandatory). No unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours\n- All arms: No other medical contraindication to protocol therapy\n- All arms: Written informed consent (and patient assent where appropriate) for therapy according to the laws of each participating country. Information must be provided to the patient on biological studies (tumour and germline), and written informed consent obtained of agreement for participation\n- All arms: National and local ethical committee approval according to the laws of each participating country (to include approval for biological studies)\n- SR: Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 22 years\n- SR: Histologically proven and genetically defined medulloblastoma including the following subtypes, as defined in the WHO classification (2016): -\tmedulloblastoma, SHH-activated and TP53-wildtype -\tmedulloblastoma, non-WNT/non-SHH \tmedulloblastoma, group 3 \tmedulloblastoma, group 4 Histologic subtype: -\tmedulloblastoma, classic -\tmedulloblastoma, desmoplastic/nodular Pre-treatment central pathology review, as well as central molecular diagnosis of genetically defined subgroup is mandatory\n- SR: No amplification of MYC or MYCN (determined by FISH or aCGH); MYCN amplification allowed for patients with group 4 medulloblastoma"}

Exclusion criteria

  • {"criterion_text":"- All arms: One of the inclusion criteria is lacking\n- LR, SR: Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or WNT subgroup status not determinable\n- LR, SR: Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF)\n- LR, SR, WNT-HR: Patient previously treated for a brain tumour or any type of malignant disease\n- LR, SR, WNT-HR: Identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. Unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours\n- SR: Identified somatic TP53 mutation in SHH activated tumours\n- SHH-TP53: Patients who refuse testing for germline TP53-mutations\n- All arms: Brainstem or supratentorial embryonal tumour\n- All arms: Atypical teratoid rhabdoid tumour\n- All arms: Patients who are pregnant\n- All arms: Female patients who are sexually active and not taking reliable contraception\n- All arms: Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons\n- All arms: Patients in whom non-compliance with toxicity management guidelines can be expected\n- LR, SR: Medulloepithelioma, embryonal tumour with multi-layered rosettes\n- LR, SR: Large cell/anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), confirmed on central pathological review"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- All arms: The primary outcome measure is event-free survival (EFS).","definition_or_measurement_approach":"Primary endpoint: event-free survival (EFS); main-objective references 3-year EFS rate for specific arms (e.g. LR: confirm 3-year EFS >80%)."}

Secondary endpoints

  • {"endpoint_text":"- All arms: The rate of overall survival (OS), and the rate of progression-free survival (PFS), estimated by the Kaplan-Meier method, are secondary outcome measures.","definition_or_measurement_approach":"OS and PFS estimated by Kaplan-Meier method."}
  • {"endpoint_text":"- All arms: Pattern of relapse is a secondary outcome measure. The site and time to local progression will be the measures for local tumour control. Particular attention will be given to posterior fossa relapse, i.e. local relapse within the tumour bed, or metastatic relapse to the posterior fossa outside the tumour bed. The time period begins on the date of surgery and ends on the date of appearance of relapse/progression. The appearance of metastases will not be regarded as local progression.","definition_or_measurement_approach":"Pattern of relapse measured by site and time to local progression; time period begins on date of surgery and ends on date of relapse/progression."}
  • {"endpoint_text":"- SR: Feasibility of carboplatin treatment concomitantly to radiotherapy is a secondary outcome measure. The timely delivery of maintenance chemotherapy, the number of interruption days, and the grade of weight change, dysphagia and esophagitis, transfusion requirement, haematological toxicities, and infection during therapy, as well as ototoxicity are measures of the feasibility of additional carboplatin.","definition_or_measurement_approach":"Feasibility measured by timely delivery of maintenance chemotherapy, number of interruption days, grades of weight change, dysphagia, esophagitis, transfusion requirement, haematological toxicities, infections, and ototoxicity."}
  • {"endpoint_text":"- All arms: Indirect measures of quality of survival (QoS) are a secondary outcome measure. Standardized, patients/ parents rated scales for measurement of health status (HUI3), executive function (BRIEF), behavioural outcome (SDQ), medical, educational, employment and social situation (MEES), Fatigue (PedsQL Multidimensional Fatigue Scale and, in adults, the MFI), and quality of life (PedsQL and, in adults, the QLQ-C30) will be the indirect measures for QoS.","definition_or_measurement_approach":"QoS measured using standardized patient/parent-rated instruments: HUI3, BRIEF, SDQ, MEES, PedsQL Multidimensional Fatigue Scale (and MFI in adults), and PedsQL/QLQ-C30 for quality of life."}
  • {"endpoint_text":"- All arms: Audiological toxicity is a secondary outcome measure. The extent of ototoxicity based dose modifications of maintenance chemotherapy, as well as the results of Pure Tone Audiometry (PTA) graded by the Chang criteria evaluated 2 years after diagnosis will be the measures for audiological toxicity.","definition_or_measurement_approach":"Audiological toxicity assessed by dose modifications due to ototoxicity and PTA graded by Chang criteria evaluated 2 years after diagnosis."}
  • {"endpoint_text":"- All arms: Endocrine function is a secondary outcome measure. FSH levels (cut-off level >15 IU/l) will be used as biomarker for subfertility. Growth retardation will be calculated as the difference in height standard deviation score (sds) from diagnosis, and the need for, time to, and duration of hormone supplementation will be used as surrogate markers for endocrine deficits. All measures will be evaluated 2 and 5 years from diagnosis/surgery and again in adulthood at 18 years.","definition_or_measurement_approach":"Endocrine function measured by FSH (>15 IU/l as biomarker for subfertility), growth SDS change, need/time/duration of hormone supplementation; evaluated at 2 and 5 years and at 18 years."}
  • {"endpoint_text":"- All arms: Neurological function is an outcome measure. The occurrence and severity of posterior fossa syndrome (as measured by the cerebellar mutism syndrome survey), and the occurrence and severity of persisting cerebellar symptoms (measured by the brief ataxia rating scale) will be the measures for neurological function.","definition_or_measurement_approach":"Neurological function assessed by cerebellar mutism syndrome survey and brief ataxia rating scale for persisting cerebellar symptoms."}
  • {"endpoint_text":"- All arms: The prognostic value of biological tumour markers is an outcome measure. Results of protein expression (including immunohistochemistry), RNA expression, and DNA analysis assays undertaken on tumour, blood or CSF material will be the measures for biological properties.","definition_or_measurement_approach":"Prognostic value assessed via protein expression (IHC), RNA expression, and DNA analyses on tumour, blood or CSF."}
  • {"endpoint_text":"- SHH-TP53: Response rate","definition_or_measurement_approach":"Response rate measured per SHH-TP53 arm (no further detail provided in record)."}
  • {"endpoint_text":"- SHH-TP53: Duration of response","definition_or_measurement_approach":"Duration of response measured per SHH-TP53 arm (no further detail provided in record)."}
  • {"endpoint_text":"- SHH-TP53: Incidence of secondary malignancies","definition_or_measurement_approach":"Incidence of secondary malignancies monitored and recorded (no further detail provided)."}
  • {"endpoint_text":"- SHH-TP53: Incidence of local, metastastatic and combined relapses in relation to radiation field (inside or outside of radiation field)","definition_or_measurement_approach":"Incidence of relapses classified by location relative to radiation field (inside/outside)."}
  • {"endpoint_text":"- SHH-TP53: Incidence of somatic, germline, and mosaic TP53 mutations","definition_or_measurement_approach":"Incidence assessed by genetic testing for somatic, germline, and mosaic TP53 mutations."}

Recruitment

Registry Or Advocacy Recruitment
True, Registry for MB occurring in the context of genetic predisposition (MB registry) is part of the study; Deutsche Kinderkrebsstiftung is listed as a source of monetary support.
Planned Sample Size
359
Recruitment Window Months
162
Consent Approach
"All arms: Written informed consent (and patient assent where appropriate) for therapy according to the laws of each participating country." Age-specific consent/assent is used: numerous age- and arm-specific subject information and informed consent forms are provided (parents/children/adolescents/adults), with country-language versions (examples include ENG, FR, NL, CZ, FI, IT, DE, SE documents listed). Parental consent and child/adolescent assent are handled per local law and with age-appropriate ICFs.

Geography

Total Number Of Sites
117
Total Number Of Participants
359

Austria

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
62
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Department für Kinder- und Jugendheilkunde
Contact Person Name
Roman Crazzolara
Contact Person Email
Roman.Crazzolara@i-med.ac.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde Med Campus IV.
Contact Person Name
Georg Ebetsberger-Dachs
Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für Pädiatrische Hämatologie/Onkologie
Contact Person Name
Martin Benesch
Contact Person Email
martin.benesch@medunigraz.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Andreas Peyrl
Contact Person Email
andreas.peyrl@meduniwien.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
27-09-2024
Processing Time Days
16
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Antwerp University Hospital
Department Name
Paediatric haemato-oncology
Contact Person Name
Joris Verlooy
Contact Person Email
joris.verlooy@uza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Paediatric haemato-oncology
Contact Person Name
Leen Willems
Contact Person Email
leen.willems@uzgent.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Paediatric haemato-oncology
Contact Person Name
Caroline Piette
Contact Person Email
caroline.piette@chuliege.be
Site Name
CHC MontLegia
Department Name
Paediatric haemato-oncology
Contact Person Name
Christophe Chantrain
Contact Person Email
christophe.chantrain@chc.be
Site Name
UZ Leuven
Department Name
Paediatric haemato-oncology
Contact Person Name
Sandra Jacobs
Contact Person Email
sandra2.jacobs@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric haemato-oncology
Contact Person Name
An Van Damme
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Paediatric haemato-oncology
Contact Person Name
Diallo Safiatou
Contact Person Email
safiatou.diallo@hubruxelles.be
Site Name
Centre Hospitalier Regional De La Citadelle (duplicate entry not expected)

Czechia

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
26-09-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
7

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Pediatric Oncology
Contact Person Name
Jaroslav Štěrba
Contact Person Email
sterba.jaroslav@fnbrno.cz

Finland

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
19
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Pirkanmaan hyvinvointialue
Department Name
Department of Pediatric Hematology and Oncology
Contact Person Name
Kristiina Nordfors
Contact Person Email
kristiina.nordfors@pirha.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Department of Pediatric Hematology and Oncology
Contact Person Name
Päivi Lähteenmäki
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Paediatric Haematology and Oncology Ward
Contact Person Name
Jouni Pesola
Site Name
HUS-Yhtymae
Department Name
Children and Adolescents
Contact Person Name
Virve Pentikäinen
Contact Person Email
virve.pentikainen@hus.fi
Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Department of pediatric hemato-oncology
Contact Person Name
Anne Hekkala
Contact Person Email
anne.hekkala@pohde.fi

France

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
28
Number Of Sites
24
Number Of Participants
86

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Liana Carausu
Contact Person Email
liana.carausu@chu-brest.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
immuno-onco-hemato-pediatrie
Contact Person Name
Anne Pagnier
Contact Person Email
APagnier@chu-grenoble.fr
Site Name
Centre Hospitalier Regional Universitaire (Besancon)
Department Name
pediatrie oncologie hematologie
Contact Person Name
Sebastien Klein
Contact Person Email
s1klein@chu-besancon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Christophe Piguet
Site Name
Centre Hospitalier Regional Universitaire (Poitiers)
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Frédéric Millot
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Nicolas Andre
Contact Person Email
Nicolas.ANDRE@ap-hm.fr
Site Name
Centre Oscar Lambret (Lille)
Department Name
Pôle Oncologie, comité pédiatrique
Contact Person Name
Sandra Raimbault
Contact Person Email
s-raimbault@o-lambret.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Justyna Kanold
Contact Person Email
jkanold@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Pediatrie
Contact Person Name
Cécile De Bouyn-Icher
Contact Person Email
celine.icher@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Pascale Blouin
Contact Person Email
p.blouin@chu-tours.fr
Site Name
Institut Gustave Roussy
Department Name
Département de cancérologie de l'enfant et de l'adolescent
Contact Person Name
Christelle Dufour
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
pediatrie oncologie hematologie
Contact Person Name
Anne-Isabelle Bertozzi
Contact Person Email
bertozzi.ai@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Antoine Gourmel
Contact Person Email
Gourmel.Antoine@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hématologie infantile
Contact Person Name
Chloé Puiseux
Contact Person Email
Chloe.PUISEUX@chu-rennes.fr
Site Name
Institut Curie
Department Name
pediatrie oncologie hematologie
Contact Person Name
François Doz
Contact Person Email
francois.doz@curie.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Gwénaëlle Duhil De Benaze
Contact Person Email
duhil-de-benaze.g@chu-nice.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Onco-hémato-immunologie pédiatrique, Service des spécialités Pôle Femme Mère Enfant
Contact Person Name
Emilie De Carli
Contact Person Email
EmDeCarli@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Damien Bodet
Contact Person Email
bodet-d@chu-caen.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Onco hématologie pédiatrique
Contact Person Name
Natacha Entz-Werle
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Gilles Palenzuela
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Onco-hématologie pédiatrique
Contact Person Name
Sandrine Thouveni-Doulet
Site Name
Centre Hospitalier Universitaire De La Reunion
Department Name
oncologie pediatrie
Contact Person Name
Yves Reguerre
Contact Person Email
yves.reguerre@chu-reunion.fr

Germany

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
10-10-2024
Processing Time Days
29
Number Of Sites
40
Number Of Participants
118

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Pädiatrische Onkologie und Hämatologie
Contact Person Name
Jörg Faber
Contact Person Email
faber@uni-mainz.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin
Contact Person Name
Toralf Bernig
Contact Person Email
toralf.bernig@uk-halle.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Kinderheilkunde III
Contact Person Name
Gudrun Fleischhack
Contact Person Email
Gudrun.Fleischhack@uk-essen.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Markus Metzler
Contact Person Email
markus.metzler@uk-erlangen.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Irene Teichert-von Lüttichau
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Kinderonkologie
Contact Person Name
Aram Prokop
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Martin Stanulla
Contact Person Email
stanulla.martin@mh-hannover.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Matthias Dürken
Contact Person Email
matthias.duerken@umm.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Michaela Nathrath
Contact Person Email
michaela.nathrath@gnh.net
Site Name
Sana Kliniken Duisburg GmbH
Department Name
Kinderklinik
Contact Person Name
Tanja Höll
Contact Person Email
tanja.hoell@sana.de
Site Name
Universitaet Leipzig
Department Name
Abteilung für Päd. Hämatologie, Onkologie und Hämostaseologie
Contact Person Name
Lars Fischer
Site Name
University Hospital Cologne AöR
Department Name
Päd. Onkologie und Hämatologie
Contact Person Name
Thorsten Simon
Contact Person Email
thorsten.simon@uk-koeln.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Pädiatrische Klinik mit Schwerpunkt Onkologie und Hämatologie
Contact Person Name
Pablo Hernáiz Driever
Contact Person Email
pablo.hernaiz@charite.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Päd. Hämatologie, Onkologie und SZT
Contact Person Name
Udo Kontny
Contact Person Email
ukontny@ukaachen.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Stefan Rutkowski
Contact Person Email
s.rutkowski@uke.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Pädiatrische Hämatologie/ Onkologie
Contact Person Name
Gabriele Calaminus
Contact Person Email
gabriele.calaminus@ukbonn.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Schwäbisches Kinderkrebszentrum
Contact Person Name
Michael Frühwald
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Kinder Onkologie,Hämatologie und Klinische Immunologie
Contact Person Name
Arndt Borkhardt
Site Name
Klinikum Dortmund gGmbH
Department Name
Westfälisches Kinderzentrum
Contact Person Name
Dominik Schneider
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Simone Hettmer
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Päd. Onkologie und Hämatologie
Contact Person Name
Paul-Gerhardt Schlegel
Contact Person Email
schlegel_p@ukw.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Antje Redlich
Contact Person Email
Antje.Redlich@med.ovgu.de
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Klinik für Kinder- und Jugendmedizin
Contact Person Name
Georg Schwabe
Contact Person Email
g.schwabe@ctk.de
Site Name
Universitaet Muenster
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Claudia Rössig
Contact Person Email
rossig@uni-muenster.de
Site Name
Asklepios Klinik Sankt Augustin GmbH
Department Name
Pädiatrische Onkologie
Contact Person Name
Harald Reinhard
Contact Person Email
H.Reinhard@asklepios.com
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Christine Mauz-Körholz
Site Name
Universitaetsmedizin Goettingen
Department Name
Päd. Onkologie und Hämatologie
Contact Person Name
Ingrid Kühnle
Contact Person Email
ikuehnle@med.uni-goettingen.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Zentrum für Kinder-, Jugend- und Frauenmedizin
Contact Person Name
Claudia Blattmann
Site Name
Gemeinschaftsklinikum Mittelrhein gGmbH
Department Name
Klinik für Kinderheilkunde und Jugendmedizin
Contact Person Name
Ümmügül Behr
Contact Person Email
Uemmueguel.behr@gk.de
Site Name
Rostock University Medical Center
Department Name
Kinder- und Jugendklinik
Contact Person Name
Carl-Friedrich Classen
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Christiane Heydrich-Karsten
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Eltern-Kind-Zentrum Prof. Hess, Kinderonkologie
Contact Person Name
Arnulf Pekrun
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Päd. Hämatologie und Onkologie
Contact Person Name
Marc Remke
Contact Person Email
marc.remke@uks.eu

Italy

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
26
Number Of Sites
13
Number Of Participants
60

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Ematologia Oncologica Pediatrica con Trapianto di Midollo Osseo
Contact Person Name
Milena La Spina
Contact Person Email
mlaspina@unict.it
Site Name
Universita Degli Studi Di Cagliari
Department Name
Oncoematologia Pediatrica
Contact Person Name
Rosamaria Mura
Contact Person Email
rosamaria.mura@aob.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale (Udine)
Department Name
Dipartimento Materno-Infantile, SOC Clinica Pediatrica
Contact Person Name
Chiara Pilotto
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Neurologia Pediatrica
Contact Person Name
Iacopo Sardi
Contact Person Email
iacopo.sardi@meyer.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oncoematologia pediatrica e centro trapianti
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UO Pediatria e Oncoematologia
Contact Person Name
Patrizia Bertolini
Contact Person Email
pbertolini@ao.pr.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. Oncoematologia Pediatrica
Contact Person Name
Elisabetta Viscardi
Contact Person Email
elisabetta.viscardi@unipd.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
UOSD Neuro-Oncologia
Contact Person Name
Claudia Milanaccio
Contact Person Email
claudiamilanaccio@gaslini.org
Site Name
Azienda Ospedaliero Universitaria Integrata Verona
Department Name
U.O.C. Oncoematologia Pediatrica
Contact Person Name
Simone Cesaro
Contact Person Email
simone.cesaro@aovr.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori (Milan)
Department Name
S.C. Pediatria Oncologica
Contact Person Name
Maura Massimino
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Oncoematologia
Contact Person Name
Angela Mastronuzzi
Contact Person Email
angela.mastronuzzi@opbg.net
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi (Ancona)
Department Name
SOSD Oncoematologia Pediatrica
Contact Person Name
Paola Coccia
Site Name
University Of Bari Aldo Moro
Department Name
Oncoematologia pediatrica
Contact Person Name
Nicola Santoro

Spain

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
27-09-2024
Processing Time Days
16
Number Of Sites
14
Number Of Participants
33

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Pediatric
Contact Person Name
Ana Llort sales
Contact Person Email
anna.llort@vallhebron.cat
Site Name
Hospital Universitario De Cruces
Department Name
Pediatric
Contact Person Name
Miguel Alejandro Garcia Ariza
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Pediatric
Contact Person Name
Carmen Garrido
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric
Contact Person Name
Eduardo Quiroga
Site Name
Hospital Universitario Reina Sofia
Department Name
Pediatric
Contact Person Name
Elena Mateos
Site Name
Hospital Universitario Miguel Servet
Department Name
Pediatric
Contact Person Name
Ascension Muñoz
Contact Person Email
amunnozmel@salud.aragon.es
Site Name
Hospital Universitario De Canarias
Department Name
Pediatric
Contact Person Name
Macarena González
Contact Person Email
macarenacruz@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Pediatric
Contact Person Name
Diego Plaza
Contact Person Email
diego_dea@yahoo.es
Site Name
Universidade De Santiago De Compostela
Department Name
Pediatric
Contact Person Name
Alexandra Regueiro Garcia
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Pediatric
Contact Person Name
Vicente Santamaría
Contact Person Email
vicente.santamaria@sjdeu.es
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric
Contact Person Name
Alvaro Lassaletta
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Pediatric
Contact Person Name
Irene Jimenez
Contact Person Email
irene.jimenez@carm.es
Site Name
Hospital Universitario De Toledo
Department Name
Pediatric
Contact Person Name
Marcos Zamora Gómez
Contact Person Email
mzamorag@sescam.jccm.es
Site Name
University Hospital Son Espases
Department Name
Pediatric
Contact Person Name
Jose-Antonio Salinas
Contact Person Email
salisanzja@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
27-09-2024
Processing Time Days
16
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Uppsala University Hospital
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Anders Öberg
Contact Person Email
anders.oberg@akademiska.se
Site Name
Karolinska University Hospital
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Stefan Holm
Contact Person Email
stefan.o.holm@sll.se
Site Name
Universitetssjukhuset I Linkoping
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Per Nyman
Site Name
Region Vaesterbotten (Umea)
Department Name
Päd. Hämatologie und Onkologie
Contact Person Name
Peer-Erik Sandström
Site Name
Region Skane Skanes Universitetssjukhus (Lund)
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Per Nyman
Principal Investigator Email
per.nyman@regionostergotland.se
Contact Person Name
Per
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen (Gothenburg)
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Magnus Sabel
Contact Person Email
magnus.sabel@vgregion.se

Netherlands

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
26-09-2024
Processing Time Days
15
Number Of Sites
1
Number Of Participants
5

Sites

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

Sponsor

Primary sponsor

Full Name
University Medical Center Hamburg-Eppendorf
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Third parties

  • {"country":"","full_name":"Deutsche Kinderkrebsstiftung","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
LOMUSTINE
Active Substance
LOMUSTINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
maxTotalDoseAmount 280 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 2650 mg/m2
Investigational Product Name
METHOTREXATE (intravenous)
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 20 gm/m2
Investigational Product Name
METHOTREXATE (intraventricular)
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENTRICULAR USE
Route
INTRAVENTRICULAR USE
Maximum Dose
maxTotalDoseAmount 48 mg
Investigational Product Name
VINCRISTINE
Active Substance
VINCRISTINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 24 mg/m2
Investigational Product Name
DOXORUBICIN HYDROCHLORIDE
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 150 mg/m2
Investigational Product Name
VINBLASTINE SULFATE
Active Substance
VINBLASTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 240 mg/m2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
maxTotalDoseAmount 16000 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
maxTotalDoseAmount 280 mg/m2
Combination Treatment
Yes

Related trials

Other published trials that may interest you.