Clinical trial • Phase III • Oncology

CARBOPLATIN for Nephroblastoma (Wilms tumour) | Metastatic (Stage IV) childhood nephroblastoma

Phase III trial of CARBOPLATIN for Nephroblastoma (Wilms tumour) | Metastatic (Stage IV) childhood nephroblastoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Nephroblastoma (Wilms tumour) | Metastatic (Stage IV) childhood nephroblastoma
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
19-04-2024
First CTIS Authorization Date
23-05-2024

Trial design

Randomised, open-label, two randomised arms: standard arm vad = vincristine + actinomycin-d (dactinomycin) + doxorubicin; experimental arm vce = vincristine + carboplatin + etoposide. (specific per-drug maximum dose parameters available in product listings; regimen schedule not fully specified in the ctis summary.)-controlled Phase III trial in Denmark, Germany, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Two randomised arms: Standard arm VAD = Vincristine + Actinomycin-D (Dactinomycin) + Doxorubicin; Experimental arm VCE = Vincristine + Carboplatin + Etoposide. (Specific per-drug maximum dose parameters available in product listings; regimen schedule not fully specified in the CTIS summary.)
Target Sample Size
389
Trial Duration For Participant
730

Eligibility

Recruits 389 paediatric patients.

Pregnancy Exclusion
Pregnancy or lactating
Vulnerable Population
The trial enrols children (<18 years). Consent must be given: subjects and, when applicable, parental/legal representative(s) must 'Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures'. Age-specific information and consent/assent materials are provided (multiple ICF and SIS documents for children, adolescents, parents/caregivers and adults in country/language-specific versions). Minors require parental/legal representative consent and age-appropriate assent/information as per the provided age-group ICF/SIS documents.

Inclusion criteria

  • {"criterion_text":"- Age <18 years >3 months\n- Patient suffering from metastatic renal tumour at initial diagnosis having at least one circumscript, non-calcified (pulmonary) nodule (or other lesion highly suspicious of metastasis according to criteria for metastatic disease) ≥3 mm as determined by chest CT-scan and abdominal CT-scan/MRI. Metastatic disease must be confirmed by central review.\n- Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the ICF prior to conducting any study related assessments/procedures\n- Able to adhere to the study visit schedule and other protocol requirements\n- No pre-existing and ongoing cardiac malfunction disease\n- No pre-existing and ongoing liver function deficiency which is not controllable by substitution\n- Metastatic childhood renal tumour must be confirmed by central review."}

Exclusion criteria

  • {"criterion_text":"- Patient and/or parental/legal representative(s) denied randomization\n- pre-existing health impairment that significantly hazards the safe treatment according to the study\n- unwillingness to follow adequate supportive measures including transfusion of blood products if medically needed\n- inability to receive chemotherapy according to the protocol, this is particulary true for: a. acute kidney failure needing dialysis treatment b. pre-existing peripheral neuropathy\n- Active, uncontrolled life threatening Infection (e.g. Acute Hepatitis, Pneumonia, AIDS, Varizella)\n- known chromosomal instability/susceptibility (e.g. Fanconi Anemia, Nijmegen Breakage Syndrome)\n- participation in other interventional trials (registration in observational noninterventional studies is acceptable)\n- age at start of treatment <3 months or >18 years\n- any other medical condition incompatible with the protocol treatment\n- primary nephrectomy\n- inability to be followed until two years after treatment\n- other chemotherapy prior to enrolment\n- other histology than nephroblastoma at diagnosis\n- Pregnancy or lactating\n- Fertile female with child bearing potential and fertile male subjects who deny the use of highly effective contraceptive measures\n- Treated by any investigational agent in a clinical study within previous 4 weeks\n- Hypersensitivity to the active substances or other excipients contained in the investigational medical products listed in the summary of product characteristics (SmPC) or Investigators Brochure (IB)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of patients with radiologic complete response (CR) of any metastasis and/or Very Good Partial Response (VGPR) of lung metastasis of childhood renal tumours after 6 weeks of preoperative chemotherapy (Section 12.5 for definitions of metastatic response)","definition_or_measurement_approach":"Radiologic response assessed after 6 weeks of preoperative chemotherapy using the protocol radiologic response criteria (see Section 12.5). The MetRR includes pulmonary response rate (PRR) and non-pulmonary response rate (NPRR); assessments are radiologic (CT/MRI) and include central review for confirmation."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of patients after 6 weeks of preoperative chemotherapy achieving a CR after surgery of metastasis at time of nephrectomy\n- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy + 9 weeks adjuvant chemotherapy.\n- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma after preoperative chemotherapy + 9 weeks adjuvant chemotherapy + metastasectomy\n- Percentage of patients with remaining metastatic disease after surgery that achieve a CR at week 9 of adjuvant chemotherapy\n- Percentage of patients with complete response +/- VGPR of (pulmonary) metastasis of nephroblastoma at the end of adjuvant chemotherapy ± metastasectomy ± RT\n- Percentage of patients with radiologic complete response (CR) of any metastasis or Very Good Partial Response (VGPR) of lung metastasis of nephroblastoma after 6 weeks of preoperative chemotherapy\n- Primary tumour volume shrinkage after 6 weeks of preoperative chemotherapy\n- Primary tumour volume after 6 weeks of preoperative chemotherapy\n- Number of metastases at diagnosis and after preoperative treatment\n- Maximum diameters of the largest metastases at diagnosis and after preoperative treatment\n- Stage distribution of local tumour\n- Histologic subtype distribution of local tumour (LR, IR, HR)\n- Histologic subtype distribution of resected nodules/metastasis (LR, IR, HR)\n- Percentage of blastema and blastemal residual volume in local tumour\n- Percentage of patients with <10 ml of blastemal residual volume in resected nephroblastoma after 6 weeks of preoperative chemotherapy\n- Percentage of necrosis in local tumour\n- Percentage of patients with complete necrosis in resected nodules\n- Percentage of patients with 1q gain being in CR/VGPR in both arms.\n- Percentage of patients requiring pulmonary radiotherapy in first line\n- Percentage of patients suffering Grade 3 or 4 ALAT or bilirubin increase during preoperative treatment\n- Percentage of patients suffering from SOS during preoperative treatment according to EBMT criteria\n- Percentage of patients suffering any Grade 4 or grade 5 toxicity during preoperative chemotherapy\n- Overall duration of preoperative treatment per arm as determined as interval D1 – date of nephrectomy\n- Delay in timing of nephrectomy: % of patients with more than 8 weeks since start of preoperative chemotherapy because of toxicity\n- Percentage of (peri-)operative complications (haemorrhage, rupture, thromboembolism)\n- Event-free survival at 2 and 5 years for the whole cohort and according to study arm (VAD/VCE) and according to 1qGain\n- Overall survival at 2 and 5 years for the whole cohort and according to study arm (VAD/VCE) and according to 1qGain","definition_or_measurement_approach":"Endpoints measured by imaging (CT/MRI) and/or surgical/pathological assessment as specified per endpoint; toxicity graded by standard CTCAE/EBMT criteria (e.g. SOS per EBMT criteria). Timing points include after 6 weeks preoperative chemotherapy, at nephrectomy, week 9 of adjuvant chemotherapy, end of adjuvant therapy, and longer-term survival follow-up at 2 and 5 years. Molecular marker (1q gain) analyses correlate marker status with CR/VGPR outcomes."}

Recruitment

Planned Sample Size
389
Recruitment Window Months
127
Consent Approach
Informed consent is required from subjects and, when applicable, parental/legal representatives prior to any study-related procedures. Age-specific information sheets and consent/assent forms are prepared (documents for children under 8, children 8-14, adolescents 12-17/14-17, older/adult participants, and parents/caregivers). Country- and language-specific ICF/SIS documents are provided (multiple versions referenced for DE, FR, NL, HU, IT, ES, CZ, NL/EN country translations etc). Minors require parental/legal representative consent and age-appropriate assent; separate materials exist for different age strata and languages.

Geography

Total Number Of Sites
97
Total Number Of Participants
389

Denmark

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
21
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Odense University Hospital
Department Name
Hans Christian Andersen Children’s Hospital
Contact Person Name
Mathias Rathe
Contact Person Email
Mathias.rathe@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Paediatrics and Adolescent Medicine
Contact Person Name
Marianne Olsen
Contact Person Email
Marianne.olsen@rn.dk
Site Name
Rigshospitalet
Department Name
Department of Paediatrics and Adolescent Medicine
Contact Person Name
Jesper Sune Brok
Contact Person Email
Jesper.sune.brok@regionh.dk
Site Name
Aarhus Universitet
Department Name
Aarhus Universitetshospital Department of Paediatrics and Adolescent Medicine
Contact Person Name
Karin Bækgaard Nissen
Contact Person Email
karins@rm.dk

Germany

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
28-05-2024
Processing Time Days
26
Number Of Sites
34
Number Of Participants
120

Sites

Site Name
Gesundheit Nordhessen Holding AG
Department Name
Kinderklinik f. päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen
Contact Person Name
Michaela Nathrath
Contact Person Email
michaela.nathrath@gnh.net
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Franz Lust Klinik für Kinder - und Jugendmedizin
Contact Person Name
Alfred Leipold
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Pädiatrische Onkologie und Hämatologie
Principal Investigator Name
Rhoikos Furtwängler
Principal Investigator Email
rhoikos.furtwaengler@uks.eu
Contact Person Name
Rhoikos Furtwängler
Contact Person Email
rhoikos.furtwaengler@uks.eu
Site Name
SLK-Kliniken Heilbronn GmbH Klinikum am Gesundbrunnen
Department Name
Klinik für Kinderheilkunde und Jugendmedizin/ Perinatalzentrum Station C62
Contact Person Name
Monika Streiter
Site Name
Diakoneo Klinik Hallerwiese-Cnopfsche Kinderklinik
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
Jörg Leyh
Contact Person Email
Joerg.Leyh@diakoneo.de
Site Name
Universitätsmedizin Greifswald
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin Abt. Pädiatrische Onkologie und Hämatologie
Contact Person Name
Stefanie Magdalena Huber
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Zentrum für Kinder- und Jugendmedizin Päd. Hämatologie und Onkologie
Contact Person Name
Johanna Scheer-Preiss
Site Name
Medical Center - University Of Freiburg
Department Name
Päd. Hämatologie/Onkologie
Contact Person Name
Alexander Puzik
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kinder- und Jugendmedizin I Hämatologie, Onkologie und Stammzelltransplantation
Contact Person Name
Simon Vieth
Contact Person Email
Simon.Vieth@uksh.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik für Kinder- und Jugendmedizin Hämatologie / Onkologie
Contact Person Name
Norbert Jorch
Contact Person Email
norbert.jorch@evkb.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Kinder und Jugendmedizin Abteilung für Pädiatrische Hämatologie, Onkologie
Principal Investigator Name
Marcus Jakob
Principal Investigator Email
marcus.jakob@klinik.uni-regensburg.de
Contact Person Name
Marcus Jakob
Site Name
Universitätsklinikum Hamburg-Eppendorf
Department Name
Pädiatrische Hämatologie/Onkologie (Haus O47)
Principal Investigator Name
Alexander von Hugo
Principal Investigator Email
a.vonhugo@uke.de
Contact Person Name
Alexander von Hugo
Contact Person Email
a.vonhugo@uke.de
Site Name
Universitätsmedizin Göttingen
Department Name
Klinik für Kinder- und Jugendmedizin Päd. Hämatologie und Onkologie
Principal Investigator Name
Christof Kramm
Principal Investigator Email
christof.kramm@med.uni-goettingen.de
Contact Person Name
Christof Kramm
Site Name
LMU Klinikum Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital
Department Name
Abteilung Onkologie/ Hämatologie
Principal Investigator Name
Irene Schmid
Principal Investigator Email
irene.schmid@med.uni-muenchen.de
Contact Person Name
Irene Schmid
Site Name
Universitätsklinikum Jena
Department Name
Klinik für Kinder- und Jugendmedizin am Universitätsklinikum Jena
Principal Investigator Name
Bernd Gruhn
Principal Investigator Email
Bernd.Gruhn@med.uni-jena.de
Contact Person Name
Bernd Gruhn
Contact Person Email
Bernd.Gruhn@med.uni-jena.de
Site Name
Medizinische Hochschule Hannover
Department Name
Zentrum für Kinderheilkunde und Jugendmedizin Klinik für Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Christin Linderkamp
Principal Investigator Email
linderkamp.christin@mh-hannover.de
Contact Person Name
Christin Linderkamp
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Kinder- und Jugendmedizin Päd. Onkologie/Hämatologie
Principal Investigator Name
Patrick Hundsdörfer
Principal Investigator Email
patrick.hundsdoerfer@helios-gesundheit.de
Contact Person Name
Patrick Hundsdörfer
Site Name
Asklepios Klinik Sankt Augustin GmbH
Department Name
Onkologie und Hämatologie
Principal Investigator Name
Harald Reinhard
Principal Investigator Email
h.reinhard@asklepios.com
Contact Person Name
Harald Reinhard
Contact Person Email
h.reinhard@asklepios.com
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin Abteilung päd. Hämatologie und Onkologie
Principal Investigator Name
Ralf Knöfler
Principal Investigator Email
ralf.knoefler@ukdd.de
Contact Person Name
Ralf Knöfler
Contact Person Email
ralf.knoefler@ukdd.de
Site Name
Universitätsklinikum Würzburg Kinderklinik und Poliklinik
Department Name
Pädiatrische Onkologie, Hämatologie und Stammzelltransplantation
Principal Investigator Name
Gerrit Weber
Principal Investigator Email
Weber_g1@ukw.de
Contact Person Name
Gerrit Weber
Contact Person Email
Weber_g1@ukw.de
Site Name
Klinikum Bremen-Mitte gGmbH
Department Name
Prof . Hess Kinderklinik
Principal Investigator Name
Stefan Fröhling
Principal Investigator Email
stefan.froehling@klinikum-bremen-mitte.de
Contact Person Name
Stefan Fröhling
Site Name
Universitätsklinikum Tübingen Klinik für Kinder- und Jugendmedizin
Department Name
Kinderheilkunde I Allgemeine Pädiatrie, Hämatologie und Onkologie
Principal Investigator Name
Stefanie Joachim
Principal Investigator Email
Stefanie.Joachim@med.uni-tuebingen.de
Contact Person Name
Stefanie Joachim
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Udo Kontny
Principal Investigator Email
ukontny@ukaachen.de
Contact Person Name
Udo Kontny
Contact Person Email
ukontny@ukaachen.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Zentrum für Kinder- und Jugendmedizin Klinik für Kinderheilkunde III Pädiatrische Hämatologie/ Onkol
Principal Investigator Name
Michael Schündeln
Principal Investigator Email
michael.schuendeln@uk-essen.de
Contact Person Name
Michael Schündeln
Contact Person Email
michael.schuendeln@uk-essen.de
Site Name
Klinikum Oldenburg AöR
Department Name
Zentrum für Kinder- und Jugendmedizin
Principal Investigator Name
Carsten Friedrich
Principal Investigator Email
friedrich.carsten@klinikum-oldenburg.de
Contact Person Name
Carsten Friedrich
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Pädiatrische Hämatologie/Onkologie/Hämostaseologie Zentrum für Kinder - und Jugendmedizin
Principal Investigator Name
Jörg Faber
Principal Investigator Email
joerg.faber@unimedizin-mainz.de
Contact Person Name
Jörg Faber
Site Name
Klinikum Dortmund gGmbH
Department Name
Westfälisches Kinderzentrum Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Dominik Schneider
Principal Investigator Email
dominik.schneider@klinikumdo.de
Contact Person Name
Dominik Schneider
Site Name
Universitätsklinikum Ulm AöR
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Lisa Nonnenmacher
Principal Investigator Email
lisa.nonnenmacher@uniklinik-ulm.de
Contact Person Name
Lisa Nonnenmacher

France

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
22
Number Of Sites
29
Number Of Participants
110

Sites

Site Name
Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)
Department Name
Institut d’Hématologie et d’Oncologie Pédiatrique (IHOP)
Principal Investigator Name
Benoît Dumont
Principal Investigator Email
Benoit.dumont@ihope.fr
Contact Person Name
Benoît Dumont
Contact Person Email
Benoit.dumont@ihope.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service d’Hémato-Immuno-Oncologie pédiatrique, Hôpital des enfants, CHU de Rouen
Principal Investigator Name
Aude Marie-Cardine
Principal Investigator Email
aude.marie-cardine@chu-rouen.fr
Contact Person Name
Aude Marie-Cardine
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Unité d’Hémato-oncologie pédiatrique, Hôpital des enfants, CHU de Bordeaux
Principal Investigator Name
Anne Notz-Carrere
Principal Investigator Email
anne.notz-carrere@chu-bordeaux.fr
Contact Person Name
Anne Notz-Carrere
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service Onco-hématologie pédiatrique, Hôpital Bretonneau CHRU de Tours
Principal Investigator Name
Jill Serre
Principal Investigator Email
j.serre@chu-tours.fr
Contact Person Name
Jill Serre
Contact Person Email
j.serre@chu-tours.fr
Site Name
Centre Oscar Lambret
Department Name
Unité d’Oncologie pédiatrique, Centre Oscar Lambret de Lille Centre régional de lutte contre le canc
Principal Investigator Name
Hélène SUDOUR-BONNANGE
Principal Investigator Email
h-sudour@o-lambret.fr
Contact Person Name
Hélène SUDOUR-BONNANGE
Contact Person Email
h-sudour@o-lambret.fr
Site Name
Institut Gustave Roussy
Department Name
Service d’Oncologie pédiatrique, Institut Gustave Roussy, Centre régional de lutte contre le cancer
Principal Investigator Name
Claudia Pasqualini
Principal Investigator Email
Claudia.PASQUALINI@gustaveroussy.fr
Contact Person Name
Claudia Pasqualini
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service d’Onco-Hématologie pédiatrique, Hôpital Archet 2 CHU de Nice
Principal Investigator Name
Joy Benadiba
Principal Investigator Email
benadiba.j@chu-nice.fr
Contact Person Name
Joy Benadiba
Contact Person Email
benadiba.j@chu-nice.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d’Hématologie oncologie pédiatrique, pédiatrie 3, CHU Hautepierre
Principal Investigator Name
Catherine Paillard
Principal Investigator Email
ccatherine.paillard@chru-strasbourg.fr
Contact Person Name
Catherine Paillard
Site Name
CHU de Besançon
Department Name
Service d’Onco-Hématologie pédiatrique, CHU de Besançon
Principal Investigator Name
Véronique Laithier
Principal Investigator Email
vlaithier@chu-besancon.fr
Contact Person Name
Véronique Laithier
Contact Person Email
vlaithier@chu-besancon.fr
Site Name
Institut Curie
Department Name
Service d’Oncologie Pédiatrique, Institut Curie
Principal Investigator Name
Gudrun Schleiemacher
Principal Investigator Email
gudrun.schleiemacher@curie.fr
Contact Person Name
Gudrun Schleiemacher
Contact Person Email
gudrun.schleiemacher@curie.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d’Oncologie et Hématologie Pédiatrique, Hôpital Timone
Principal Investigator Name
Arnauld Verschuur
Principal Investigator Email
arnauld.verschuur@ap-hm.fr
Contact Person Name
Arnauld Verschuur
Contact Person Email
arnauld.verschuur@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d’Hémato-Immuno-Oncologie pédiatrique, Hôpital des Enfants, CHU de Toulouse
Principal Investigator Name
Cécile Boulanger
Principal Investigator Email
Boulanger.c@chu-toulouse.fr
Contact Person Name
Cécile Boulanger
Contact Person Email
Boulanger.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hématologie pédiatrique, Hôpital d’enfants CHU de Dijon
Principal Investigator Name
Claire Briandet
Principal Investigator Email
claire.briandet@chu-dijon.fr
Contact Person Name
Claire Briandet
Contact Person Email
claire.briandet@chu-dijon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Unité d’Onco-Hématologie pédiatrique, CHU de Limoges
Principal Investigator Name
Christophe Piguet
Principal Investigator Email
christophe.piguet@chu-limoges.fr
Contact Person Name
Christophe Piguet
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Département de Pédiatrie et Génetique Médicale, Hôpital Morvan, CHU de Brest
Principal Investigator Name
Liana-Stefania Carausu
Principal Investigator Email
liana.carausu@chu-brest.fr
Contact Person Name
Liana-Stefania Carausu
Contact Person Email
liana.carausu@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De La Reunion
Department Name
Service d’Hématologie et Oncologie pédiatrique, CHU de la Réunion
Principal Investigator Name
Yves Reguerre
Principal Investigator Email
yves.reguerre@chu-reunion.fr
Contact Person Name
Yves Reguerre
Contact Person Email
yves.reguerre@chu-reunion.fr
Site Name
Centre Hospitalier Universitaire De La Grenoble Alpes
Department Name
Service d’Immuno-Hématologie et oncologie pédiatrique, Hôpital Couple-enfant, CHU de Grenoble
Principal Investigator Name
Cécile Perret
Principal Investigator Email
cperret1@chu-grenoble.fr
Contact Person Name
Cécile Perret
Contact Person Email
cperret1@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Unité d’Hématologie et oncologie pédiatrique, CHU de St Etienne, Hôpital Nord
Principal Investigator Name
Sandrine Thouvenin-Doulet
Principal Investigator Email
sandrine.thouvenin@chu-st-etienne.fr
Contact Person Name
Sandrine Thouvenin-Doulet
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d’ Hématologie et Oncologie pédiatrique, CHU de Poitiers
Principal Investigator Name
Frédéric Millot
Principal Investigator Email
f.millot@chu-poitiers.fr
Contact Person Name
Frédéric Millot
Contact Person Email
f.millot@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d’ Hématologie Oncologie pédiatrique, Hôpital Arnaud de Villeneuve CHU de Montpellier
Principal Investigator Name
Stéphanie Haouy
Principal Investigator Email
s-haouy@chu-montpellier.fr
Contact Person Name
Stéphanie Haouy
Contact Person Email
s-haouy@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service d’Hémato-oncologie pédiatrique, Hôpital Américain CHU Reims
Principal Investigator Name
Claire Pluchart
Principal Investigator Email
cpluchart@chu-reims.fr
Contact Person Name
Claire Pluchart
Contact Person Email
cpluchart@chu-reims.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service d’Hémato-Oncologie pédiatrique, CHU Estaing de Clermont-Ferrand
Principal Investigator Name
Justyna Kanold
Principal Investigator Email
jkanold@chu-clermontferrand.fr
Contact Person Name
Justyna Kanold
Contact Person Email
jkanold@chu-clermontferrand.fr
Site Name
Centre Hospitalier Universitaire De Amiens Picardie
Department Name
Service d’Oncologie Hématologie pédiatrique, CHU de d’Amiens
Principal Investigator Name
Antoine Gourmel
Principal Investigator Email
gourmel.antoine@chu-amiens.fr
Contact Person Name
Antoine Gourmel
Contact Person Email
gourmel.antoine@chu-amiens.fr
Site Name
CHRU De Nancy
Department Name
Service d’Onco-hématologie pédiatrique, Hôpital d’enfants, CHU de Nancy
Principal Investigator Name
Ludovic Mansuy
Principal Investigator Email
lu.mansuy@chru-nancy.fr
Contact Person Name
Ludovic Mansuy
Contact Person Email
lu.mansuy@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Unité d’Oncohématologie Pédiatrique, CHU de Caen
Principal Investigator Name
Damien Bodet
Principal Investigator Email
bodet-d@chu-caen.fr
Contact Person Name
Damien Bodet
Contact Person Email
bodet-d@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d’ Hématologie et Oncologie pédiatrique, CHU de Nantes
Principal Investigator Name
Estelle Thebaud
Principal Investigator Email
estelle.thebaud@chu-nantes.fr
Contact Person Name
Estelle Thebaud
Contact Person Email
estelle.thebaud@chu-nantes.fr
Site Name
Hôpital Sud, CHU de Rennes
Department Name
Service d’ Hématologie et Oncologie pédiatrique, Hôpital Sud, CHU de Rennes
Principal Investigator Name
Chloé Puiseux
Principal Investigator Email
chloe.puiseux@chu-rennes.fr
Contact Person Name
Chloé Puiseux
Contact Person Email
chloe.puiseux@chu-rennes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Hématologie et Oncologie pédiatrique, Hôpital Armand-Trousseau, AP-HP
Principal Investigator Name
Marie-Dominique Tabone
Principal Investigator Email
marie-dominique.tabone@ap-hp.fr
Contact Person Name
Marie-Dominique Tabone
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service d’Immuno-Hémato-Oncologie pédiatrique, CHU de Angers, Bât Robert Debré
Principal Investigator Name
Isabelle Pellier
Principal Investigator Email
ispellier@chu-angers.fr
Contact Person Name
Isabelle Pellier
Contact Person Email
ispellier@chu-angers.fr

Austria

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
28-05-2024
Processing Time Days
26
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
Medical University Of Graz
Department Name
Univ.-Klinik für Kinder- und Jugendheilkunde Klinische Abteilung für Pädiatrische Hämatologie/Onkolo
Principal Investigator Name
Martin Benesch
Principal Investigator Email
martin.benesch@medunigraz.at
Contact Person Name
Martin Benesch
Contact Person Email
martin.benesch@medunigraz.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Pädiatrie I Department für Kinder- und Jugendheilkunde
Principal Investigator Name
Roman Crazzolara
Principal Investigator Email
Roman.crazzolara@i-med.ac.at
Contact Person Name
Roman Crazzolara
Contact Person Email
Roman.crazzolara@i-med.ac.at
Site Name
Johannes Kepler University Linz
Department Name
Universitätsklinikum für Kinder –u. Jugendheilkunde
Principal Investigator Name
Renate Steiner
Principal Investigator Email
renate.steiner@kepleruniklinikum.at
Contact Person Name
Renate Steiner
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Kinderspital / Abteilung für Kinder- und Jugendheilkunde
Principal Investigator Name
Neil Jones
Principal Investigator Email
neil.jones@salk.at
Contact Person Name
Neil Jones
Contact Person Email
neil.jones@salk.at
Site Name
St. Anna Kinderspital GmbH
Department Name
Hämatologische, Onkologische und Immunologische Abteilung
Principal Investigator Name
Leila Ronceray
Principal Investigator Email
leila.ronceray@stanna.at
Contact Person Name
Leila Ronceray
Contact Person Email
leila.ronceray@stanna.at

Belgium

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
22
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Antwerp University Hospital
Department Name
Paediatric haemato oncology
Principal Investigator Name
Jaques Van Heerden
Principal Investigator Email
jaques.vanheerden@uza.be
Contact Person Name
Jaques Van Heerden
Contact Person Email
jaques.vanheerden@uza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Paediatric haemato oncology
Principal Investigator Name
Bram De Wilde
Principal Investigator Email
bram.dewilde@uzgent.be
Contact Person Name
Bram De Wilde
Contact Person Email
bram.dewilde@uzgent.be
Site Name
CHC MontLegia
Department Name
Paediatric haemato oncology
Principal Investigator Name
Lucie Rouffiange
Principal Investigator Email
lucie.rouffiange@chc.be
Contact Person Name
Lucie Rouffiange
Contact Person Email
lucie.rouffiange@chc.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Paediatric haemato oncology
Principal Investigator Name
Christine Devalck
Principal Investigator Email
christine.devalck@huderf.be
Contact Person Name
Christine Devalck
Contact Person Email
christine.devalck@huderf.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Paediatric haemato oncology
Principal Investigator Name
Sophie Gatineau
Principal Investigator Email
Sophie.Gatineau@chrcitadelle.be
Contact Person Name
Sophie Gatineau
Site Name
UZ Leuven
Department Name
Paediatric haemato oncology
Principal Investigator Name
Heidi Segers
Principal Investigator Email
Heidi.segers@uzleuven.be
Contact Person Name
Heidi Segers
Contact Person Email
Heidi.segers@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric haemato oncology
Principal Investigator Name
Benedicte Brichard
Principal Investigator Email
benedicte.brichard@uclouvain.be
Contact Person Name
Benedicte Brichard

Netherlands

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
23-05-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Solid Tumours
Principal Investigator Name
Martine Van Grotel
Principal Investigator Email
m.vangrotel@prinsesmaximacentrum.nl
Contact Person Name
Martine Van Grotel

Czechia

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
160
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Department of Pediatric Hematology and Oncology
Principal Investigator Name
Karel Švojgr
Principal Investigator Email
karel.svojgr@fnmotol.cz
Contact Person Name
Karel Švojgr
Contact Person Email
karel.svojgr@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Department of Pediatric Oncology
Principal Investigator Name
Viera Bajčiová
Principal Investigator Email
bajciova.viera@fnbrno.cz
Contact Person Name
Viera Bajčiová
Contact Person Email
bajciova.viera@fnbrno.cz

Hungary

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
56
Number Of Sites
2
Number Of Participants
1

Sites

Site Name
University Of Pecs
Department Name
Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika
Principal Investigator Name
Gabor Ottoffy
Principal Investigator Email
ottoffy.gabor@pte.hu
Contact Person Name
Gabor Ottoffy
Contact Person Email
ottoffy.gabor@pte.hu
Site Name
Semmelweis University
Department Name
Gyermekgyogyaszati Klinika
Principal Investigator Name
Sandor Szabo
Principal Investigator Email
szabo.sandor@gyerekklinika.com
Contact Person Name
Sandor Szabo
Contact Person Email
szabo.sandor@gyerekklinika.com

Italy

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
23
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
Dipartimento di Pediatria Centro Trapianto Cellule staminali Emopoietiche per pazienti Pediatrici
Principal Investigator Name
Francesco De Leonardis
Principal Investigator Email
fdl111@libero.it
Contact Person Name
Francesco De Leonardis
Contact Person Email
fdl111@libero.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia medica ed Ematologia Pediatrica
Principal Investigator Name
Marta Podda
Principal Investigator Email
marta.podda@istitutotumori.mi.it
Contact Person Name
Marta Podda
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Onco-Ematologia Pediatrica
Principal Investigator Name
Franca Fagioli
Principal Investigator Email
franca.fagioli@unito.it
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Area Studi Clinici Oncoematologici e Terapie Cellulari
Principal Investigator Name
Annalisa Serra
Principal Investigator Email
annalisa.serra@opbg.net
Contact Person Name
Annalisa Serra
Contact Person Email
annalisa.serra@opbg.net
Site Name
Azienda Ospedaliera di Padova
Department Name
Oncoematologia Pediatrica
Principal Investigator Name
Gianni Bisogno
Principal Investigator Email
gianni.bisogno@unipd.it
Contact Person Name
Gianni Bisogno
Contact Person Email
gianni.bisogno@unipd.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O.C. Ematologia ed Oncologia Pediatrica
Principal Investigator Name
Andrea Di Cataldo
Principal Investigator Email
adicata@unict.it
Contact Person Name
Andrea Di Cataldo
Contact Person Email
adicata@unict.it

Spain

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
40
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Hospital Universitario De Cruces
Department Name
Pediatric Oncohematology
Principal Investigator Name
Rosa María Adán Pedroso
Principal Investigator Email
rosaadanpedroso@gmail.com
Contact Person Name
Rosa María Adán Pedroso
Contact Person Email
rosaadanpedroso@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Pediatric Oncology
Principal Investigator Name
Guiomar Gutiérrez Schiaffino
Principal Investigator Email
guiogs@hotmail.com
Contact Person Name
Guiomar Gutiérrez Schiaffino
Contact Person Email
guiogs@hotmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Oncohematology
Principal Investigator Name
Julia Balaguer Guill
Principal Investigator Email
Balaguer_jul@gva.es
Contact Person Name
Julia Balaguer Guill
Contact Person Email
Balaguer_jul@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pediatric Oncology
Principal Investigator Name
Anna Llort
Principal Investigator Email
anna.llort@vallhebron.cat
Contact Person Name
Anna Llort
Contact Person Email
anna.llort@vallhebron.cat
Site Name
Hospital Universitario La Paz
Department Name
Pediatric Oncohematology
Principal Investigator Name
Pedro María Rubio Aparicio
Principal Investigator Email
pedro.rubio@salud.madrid.org
Contact Person Name
Pedro María Rubio Aparicio
Contact Person Email
pedro.rubio@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric Oncohematology
Principal Investigator Name
Gema Lucía Ramírez
Principal Investigator Email
gemal.ramirez@juntadeandalucia.es
Contact Person Name
Gema Lucía Ramírez
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric Oncohematology
Principal Investigator Name
Ana Isabel Benito Bernal
Principal Investigator Email
anaisabel.benito.bernal@salud.madrid.org
Contact Person Name
Ana Isabel Benito Bernal

Sponsor

Primary sponsor

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

Third parties

  • {"country":"Germany","full_name":"Zentrum fuer Forschungsfoerderung in der Paediatrie GmbH","duties_or_roles":"codes: 1,12","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Paediatrisches Forschungsnetzwerk gGmbH","duties_or_roles":"codes: 1,12","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Universitaetsklinikum des Saarlandes AöR","duties_or_roles":"codes: 11,13,2,5,6,8","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
Authorisation Status
prodAuthStatus=2 (authorisation information present in product listing)
Maximum Dose
max daily dose 200 mg/m2; max total dose 1200 mg/m2
Investigational Product Name
DACTINOMYCIN
Active Substance
DACTINOMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
prodAuthStatus=2 (authorisation information present in product listing)
Maximum Dose
max daily dose 45 µg/kg; max total dose 135 µg/kg
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus=2 (authorisation information present in product listing)
Maximum Dose
max daily dose 100 mg/m2; max total dose 600 mg/m2
Investigational Product Name
Vincristine Sulfate 1 mg/ml Solution for Injection or Infusion
Active Substance
VINCRISTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 12082 in CY listed)
Maximum Dose
max daily dose 1.5 mg/m2; max total dose 9 mg/m2
Investigational Product Name
DOXORUBICIN HYDROCHLORIDE
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus=2 (authorisation information present in product listing)
Maximum Dose
max daily dose 50 mg/m2; max total dose 100 mg/m2
Combination Treatment
Yes

Related trials

Other published trials that may interest you.