High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
NCT ID: NCT04221035
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2019-11-05
2032-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
NCT01704716
Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma
NCT02025881
Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma
NCT00030719
Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
NCT00070200
Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma
NCT00410631
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The first randomization (R-I) will compare the efficacy of two induction chemotherapies (RAPID COJEC and GPOH regimens) in a phase III setting. The primary endpoint will be the 3-year EFS from date of randomization . The R-I randomization will be stratified on age, stage, MYCN status and countries.
The second randomization (R-HDC) will compare the efficacy of single HDC with Bu-Mel versus tandem HDC with Thiotepa followed by Bu-Mel. The primary endpoint is 3-year EFS calculated from the date of the R-HDC randomization. The R-HDC randomization will be stratified on the age, stage, MYCN status, induction chemotherapy regimen, response to induction phase and countries.
The impact of local treatment in this phase III setting will be assessed, according to the presence or not of a macroscopic residual disease after surgery and HDC.
In case of macroscopic residual disease, 21.6 Gy radiotherapy to the preoperative tumor bed will be randomized (R-RTx) versus the same treatment plus a sequential boost of additional 14.4 Gy to the residual tumor. The primary endpoint of R-RTx is 3-year EFS from the date of the R-RTx randomization. The R-RTx randomization will be stratified on age, stage, MYCN status, induction chemotherapy regimen, HDC regimen and countries.
In case of no macroscopic residual disease, 21.6 Gy radiotherapy will be delivered to the preoperative tumor bed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
phase induction-R-I
R-I: induction regimens RAPID COJEC vs GPOH Assuming a baseline 3-year EFS of 40%, with a sample size of 686 patients (343 in each arm) and a two-sided alpha=5% this trial will have 90% power to demonstrate an improvement of 12% in 3-year EFS, within a recruitment period of 3 years and a minimum follow up of 1.5 years.
Patients with insufficient metastatic response at the end of induction chemotherapy, defined as SIOPEN score \> 3 or less than 50% reduction in mIBG score (or \> 3 bone lesions or less 50% reduction in number of FDG-PET-avid bone lesions for mIBG-non avid tumours), have a poorer prognosis.
Chemoimmunotherapy arm Metastatic response rate after 4 courses of irinotecan-temozolomide (TEMIRI) combined with dinutuximab beta (DB) in patients with insufficient metastatic response at the end of induction chemotherapy (TEMIRI/DB).
Vincristine
1.5 mg/m2 (max dose 2 mg)
Carboplatin
750 mg/m2
Etoposide
175 mg/m2
Vindesine
3 mg/m2/day (max dose 6 mg)
Dacarbazine
200 mg/m2/day
Ifosfamide
1500 mg/m2/day
Doxorubicin
30 mg/m2/dose
Dinutuximab Beta
Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day
Cisplatin
80 mg/m2/24h
Temozolomide 100 MG
100 mg/m²/Day
Irinotecan
50 mg/m²/jour de J0 à J4
Cyclophosphamid
Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.
Phase high dose chemotherapy consolidation
R-HDC: consolidation regimen Bu-Mel vs Thiotepa + Bu-Mel The 3-year EFS in the Bu-Mel arm (with immunotherapy) is estimated to be 55%. This study aims to show an improvement of 12% for the Thiotepa + Bu-Mel arm (3-year EFS of 67%). With a recruitment of 448 patients (224 in each arm) over a period of 3 years and a minimum follow-up of 2 years, the power to show a 12% difference is 80% (two-sided logrank test and α=5%).
Busulfan
\< 9kg: 1.0 mg/kg/dose 9 kg to \< 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose \>23 kg to 34 kg: 0.95 mg/kg/dose \>34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses
Melphalan
140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose
Thiotepa
300 mg/m2/day over 2 hours
Phase of radiotherapy
R-RTx: 21.6 Gy radiotherapy vs 21.6 Gy + 14.4 Gy boost in patients with macroscopic residual disease
Radiotherapy
21.6 Gy 21.6 Gy + boost de 14.4 Gy
Dinutuximab Beta
Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vincristine
1.5 mg/m2 (max dose 2 mg)
Carboplatin
750 mg/m2
Etoposide
175 mg/m2
Vindesine
3 mg/m2/day (max dose 6 mg)
Dacarbazine
200 mg/m2/day
Ifosfamide
1500 mg/m2/day
Doxorubicin
30 mg/m2/dose
Busulfan
\< 9kg: 1.0 mg/kg/dose 9 kg to \< 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose \>23 kg to 34 kg: 0.95 mg/kg/dose \>34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses
Melphalan
140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose
Thiotepa
300 mg/m2/day over 2 hours
Radiotherapy
21.6 Gy 21.6 Gy + boost de 14.4 Gy
Dinutuximab Beta
Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day
Cisplatin
80 mg/m2/24h
Temozolomide 100 MG
100 mg/m²/Day
Irinotecan
50 mg/m²/jour de J0 à J4
Cyclophosphamid
Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at diagnosis before the beginning of chemotherapy or
* up to 21 days after one course of Carboplatin-Etoposide for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification or patients with metastatic neuroblastoma treated in emergency or
* up to 21 days after one course of the current protocol for R-I randomisation (RAPID COJEC/GPOH) low/intermediate risk neuroblastoma in Germany/Netherlands for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification
HR-NBL2 eligibility criteria:
1. Established diagnosis of neuroblastoma according to the SIOPEN- modified International Neuroblastoma Risk Group (INRG) criteria, High-risk neuroblastoma defined as:
* Stage M neuroblastoma above 365 days of age at diagnosis (no upper age limit) and Ms neuroblastoma 12-18 months old, any MYCN status or
* L2, M or Ms neuroblastoma any age with MYCN amplification, or focal high level MYC or MYCL amplification.
In Germany, patients aged less than 18 months with stage M and without MYCN amplification will not be enrolled in HR-NBL2 trial.
2. No previous chemotherapy or up to 21 days after one cycle of Carboplatin-Etoposide chemotherapy for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification or patients with metastatic neuroblastoma treated in emergency or up to 21 days after one course of the current protocol for low/intermediate risk neuroblastoma in Germany/Netherlands for patients with localized neuroblastoma or infants with metastatic neuroblastoma with MYCN amplification
3. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on HR-NBL2 study and for one year after stopping the study. Acceptable contraception is defined in CTFG Guidelines "Recommendations related to contraception and pregnancy testing in clinical trials" (Appendix 11). Female patients who are lactating must agree to stop breast-feeding.
4. Written informed consent to enter the HR-NBL2 protocol from patient or parents/legal representative, patient, and age-appropriate assent.
5. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
6. Patients should be able and willing to comply with study visits and procedures as per protocol
R-I eligibility criteria:
\- Written informed consent to enter the R-I randomisation from patient or parents/legal representative, patient, and age- appropriate assent.
2. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving his consent.
3. Participating in another clinical study with an IMP while on study treatment.
4. Chronic inflammatory bowel disease and/or bowel obstruction.
5. Pregnant or breastfeeding women.
6. Known hypersensitivity to the active substance or to any of the excipients of the study drugs
7. Concomitant self-medication medicine that in the investigator opinion could interact with study treatments, including herbal medicine (e.g. St John's Wort (Hypericum Perforatum).
1. Urinary tract obstruction ≥ grade 3
2. Heart failure or myocarditis ≥ grade 2, any arrhythmia or myocardial infection
3. Peripheral motor or sensory neuropathy ≥ grade 3
4. Demyelinating form of Charcot-Marie-Tooth syndrome
5. Hearing impairment ≥ grade 2
6. Concurrent prophylactic use of phenytoin
7. Cardiorespiratory disease that contraindicates hyperhydration
2. Liver function: Alanine aminotransferase (ALT) \> 3.0 x ULN and blood bilirubin \> 1.5 x ULN (toxicity ≥ grade 2). In case of toxicity ≥ grade 2, call national principal investigator study coordinator to discuss the feasibility.
3. Renal function: Creatinine clearance and/or GFR \< 60 ml/min/1.73m² (toxicity ≥ grade 2). If GFR \< 60ml/min/1.73m², call national principal investigator study coordinator to discuss about the treatment.
4. Dyspnea at rest and/or pulse oximetry \<95% in air (only for R-HDC, and R-RTx)
5. Any uncontrolled intercurrent illness or infection that in the investigator opinion would impair study participation.
6. Concomitant use with yellow fever vaccine and with live virus or bacterial vaccines.
7. Patient allergic to peanut or soya.
Exclusion Criteria
Randomisation for HDC strategy will be performed at the end of induction after the disease evaluation and after surgery of the primary tumour for those patients who will receive surgery before HDC.
R-HDC eligibility criteria:
1. \- Stage M neuroblastoma above 365 days of age at diagnosis, any MYCN status, EXCEPT patients with stage M or Ms 12-18 months old with numerical chromosomal alterations only, and in complete metastatic response at the end of induction: in this case, patients will have surgery and no further treatment.
OR
\- L2, M or Ms neuroblastoma, any age, with MYCN amplification, or focal high level MYC or MYCL amplification
2. Age \< 21 years at the time of randomization
3. Complete response (CR) or partial response (PR) at metastatic sites:
* Bone disease: mIBG uptake completely resolved or SIOPEN score ≤ 3 and at least 50% reduction in mIBG score (or ≤ 3 bone lesions and at least 50% reduction in number of FDG- PET-avid bone lesions for mIBG-nonavid tumours).
* Bone marrow disease: CR and/or minimal disease (MD) according to International Neuroblastoma Response Criteria
* Other metastatic sites: CR. (after induction chemotherapy +/- surgery), except for distant lymph nodes for which PR is accepted with a possible secondary surgery
4. Acceptable organ function and performance status:
* Performance status ≥ 50%.
* Hematological status: ANC\>0.5x109/L, platelets \> 20x 109/L
* Cardiac function: (\< grade 2)
* Normal chest X-Ray and oxygen saturation.
* Absence of any toxicity ≥ grade 3. 4) Sufficient collected stem cells available; a total harvest of at least 6 x 106/kg CD34+ cells, to be stored in at least 4 separate bags to administer at least 3 x 106/kg CD34+ cells per rescue.
5. Written informed consent, including agreement of patient or parents/legal guardian for minors, to enter the R-HDC randomisation.
6. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
7. Patients should be able and willing to comply with study visits and procedures as per protocol.
In case of parents'/patient's refusal, or insufficient stem cells, collection for tandem HDC but with a minimum of 3 x 106 CD34+ cells/kg body weight, or in case of patients older than 21 years, or organ toxicity, HDC will consist on the standard HD Bu-Mel and patients will be eligible for the subsequent randomisation.
R-RTx randomisation (Local Radiotherapy) Chemoimmunotherapy arm
R-RTx eligibility criteria:
An evaluation of the local disease will be performed after HDC/ASCR and surgery:
* In case of no local macroscopic disease, all patients will receive 21,6-Gy radiotherapy to the pre-operative tumour bed
* In case of local macroscopic residual disease, patients will be eligible to R-RTx if the following criteria are met:
1. No evidence of disease progression after HDC/ASCR.
2. Interval between the last ASCR and radiotherapy start between 60 and 90 days.
3. Performance status greater or equal 50%.
4. Hematological status: ANC \>0.5x109/L, platelets \> 20x109/L.
5. Written informed consent, including agreement of patient or parents/legal guardian for minors, to enter the R-RTx randomisation.
6. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
7. Patients should be able and willing to comply with study visits and procedures as per protocol.
In case of parents'/patient's refusal of the randomisation, the patient will receive 21.6 Gy radiotherapy to the pre-operative tumour bed.
Chemoimmunotherapy arm eligibility criteria:
1. Insufficient metastatic response at the end of induction chemotherapy, defined as:
* SIOPEN score \> 3 or less than 50% reduction in mIBG score (or \> 3 bone lesions or less 50% reduction in number of FDG-PET-avid bone lesions for mIBG-non avid tumours) OR
* Bone marrow disease: SD according to International Neuroblastoma Response Criteria OR
* Other metastatic sites: PR or SD. For distant lymph nodes: PR and not resectable or SD.
2. Performance status ≥ 50%.
3. Hematological status: ANC\>0.75x109/L without G-CSF for at least 48 hours (or ANC ≥ 0.50 x 109 /L in case of bone marrow involvement), platelets \> 50x 109/L and rising, without platelets transfusion for 72 hours.
4. AST or ALT ≤7.5 ULN and total bilirubin ≤1.5 ULN. In patients with liver metastases, total bilirubin ≤2.5 ULN is allowed.
5. No active infection;
6. No grade \>2 gastrointestinal toxicity.
7. No grade ≥ 3 toxicity related to previous treatment.
8. Oxygen saturation \> 94%
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claudia Pasqualini, MD PhD
Role: STUDY_CHAIR
Gustave roussy, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sydney children Hospital
Sydney, Randwick, Australia
Children's Cancer Centre, Monash Children's Hospital
Clayton, , Australia
Oncology/Haematology Department, Perth Children's Hospital
Nedlands, , Australia
Children's Cancer & Haematology Services, John Hunter Children's Hospital
New Lambton Heights, , Australia
Australian and New Zealand Children's Hematology/oncology Group
Sydney, , Australia
sydney children Hospital
Sydney, , Australia
Cancer Centre for Children, The Children's Hospital
Westmead, , Australia
Medical University Graz
Graz, , Austria
Landeskrankenhaus-Universitätsklinikum Innsbruck
Innsbruck, , Austria
Kepler Universitatsklinikum Linz
Linz, , Austria
Universitastsklinikum Salzburg
Salzburg, , Austria
St Anna'S Children Hospital
Vienna, , Austria
Hôpital Universitaire des Enfants Reine Fabiola (ULB)
Brussels, , Belgium
Cliniques Universitaires Saint-Luc (UCL)
Brussels, , Belgium
University Hospital Gent
Ghent, , Belgium
University Hospitals Leuven
Leuven, , Belgium
CHR Citadelle
Liège, , Belgium
University Hospital Motol
Prague, Prague, Czechia
Klinika dětské onkologie FN Brno
Brno, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen, , Denmark
The Hans Christian Andersen Children's Hospital, University of Southern Denmark
Odense, , Denmark
New Children's Hospital, Helsinki University Hospital, Helsinki and Uusimaa Hospital District
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Gustave Roussy
Villejuif, Val De Marne, France
CHU d'AMIENS
Amiens, , France
CHU angers
Angers, , France
CHU-Pôle Médico-Chirurgical de l'Enfant et l'Adolescant
Besançon, , France
CHU Bordeaux
Bordeaux, , France
Groupe Hospitalier Pellegrin - Chu - Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
CHU Brest - Hôpital du Morvan
Brest, , France
Centre François Baclesse
Caen, , France
CHU de Caen
Caen, , France
CHU Estaing
Clermont-Ferrand, , France
Centre Georges-François Leclerc
Dijon, , France
Hopital d'enfants Marechal de lattre
Dijon, , France
Hôpital Couple-Enfant CHU de Grenoble
Grenoble, , France
Chu de La Reunion - St Denis
La Réunion, , France
centre Oscar lambert
Lille, , France
Hôpital de la Mère et de l'Enfant - CHU Limoges
Limoges, , France
Centre Léon Berard
Lyon, , France
hopital la Timone
Marseille, , France
CHRU Nancy-Hôpital Brabois Enfant
Nancy, , France
Institut de cancérologie de Loraine
Nancy, , France
Centre Antoine Lacassagne
Nice, , France
CHU Nice-Hôpital d'Archet
Nice, , France
Hôpital Armand Trousseau
Paris, , France
institut Curie
Paris, , France
CHU Poitiers
Poitiers, , France
Hôpital Américain -CHU Reims
Reims, , France
Centre Eugène Marquis
Rennes, , France
CHU Rennes
Rennes, , France
Hôpital des Enfants - CHU Rouen
Rouen, , France
CHU Saint Etienne
Saint-Etienne, , France
Institut de cancérologie de l'Ouest - Sité René Gauducheau
Saint-Herblain, , France
CHU Haute Pierre
Strasbourg, , France
Institut de Cancérologie Strasbourg
Strasbourg, , France
Hopital des enfants-CHU Toulouse
Toulouse, , France
IUCT Oncopole
Toulouse, , France
CHU Tours Hôpital Clocheville
Tours, , France
charite universitatsmedizin Berlin
Berlin, , Germany
Uniklinik Köln, Klinik und Poliklinik für Kinder und Jugendmedizin
Cologne, , Germany
Children's General Hospital "I AGHIA SOFIA"
Athens, , Greece
Children's General Hospital "P. & A. KYRIAKOU"
Athens, , Greece
"MITERA" Private, General, Obstetrics - Gynaecology, Paediatric Clinic S.A.
Athens, , Greece
Children's General Hospital "AGHIA SOFIA"
Athens, , Greece
University General Hospital of Heraklion (UnGHH)
Heraklion, , Greece
University General Hospital of Thessaloniki "AHEPA"
Thessaloniki, , Greece
General Hospital of Thessaloniki "IPPOKRATIO"
Thessaloniki, , Greece
RAMBAM Medical Center
Haifa, , Israel
A.O.U Policlinico di Bari
Bari, , Italy
Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO
Brescia, , Italy
policlinico rodolico San marco
Catania, , Italy
Azienda ospedaliero universtaria Anna Meyer
Florence, , Italy
instituto Giannina Gaslini genova
Genova, , Italy
IRCCS "Istituto Giannina Gaslini"
Genova, , Italy
Azienda Policlinico di Modena
Modena, , Italy
Azienda ospedaliero universitaria di Parma
Parma, , Italy
Policlino San matteo di Pavia
Pavia, , Italy
U.O Pediatria, SS Oncoematologia pediatrica
Rimini, , Italy
IRCCS Burlo Garoflo oncoematologia
Trieste, , Italy
U.O.C oncoematologia pediatrica ospedale Donna Bambino
Verona, , Italy
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
National Cancer Institute
Vilnius, , Lithuania
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Princess Maxima center
Utrecht, , Netherlands
Haukeland University Hospital
Haukeland, , Norway
Oslo University Hospital
Oslo, , Norway
University Hospital Northern Norway, Tromsoe
Tromsø, , Norway
St Olavs Hospital,
Trondheim, , Norway
Children's University Hospital Banská Bystrica
Banská Bystrica, , Slovakia
NÚDCH- National Institute of Children's Diseases,
Bratislava, , Slovakia
Children's University Hospital Košice
Košice, , Slovakia
University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia
Ljubljana, , Slovenia
Hospital Universitario Son Espases
Balea, , Spain
Hospital Universitario Vall D´Hebron
Barcelona, , Spain
Hospital Universitario Cruces
Cruces, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Universitario Infantil Niño Jesús
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Politécnico de La FE
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Linköping University Hospital
Linköping, , Sweden
Skåne University Hospital
Lund, , Sweden
Karolinska University Hospital, Stockholm
Stockholm, , Sweden
Norrland University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Kantonsspital Aarau AG Klinik für Kinder und Jugendliche
Aarau, , Switzerland
Universitäts-Kinderspital beider Basel (UKBB)
Basel, , Switzerland
Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica
Bellinzona, , Switzerland
Inselspital, Universitätsklinik für Kinderheilkunde
Bern, , Switzerland
HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique
Geneva, , Switzerland
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie
Lucerne, , Switzerland
Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6
Sankt Gallen, , Switzerland
Division of Pediatric Oncology Universitäts-Kinderspital Zürich
Zurich, , Switzerland
Royal Aberdeen Children's Hospital
Aberdeen, , United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Birmingham children's Hospital
Birmingham, , United Kingdom
University Hospitals Birmingham Queen Elisabeth Hospital(UHB)
Birmingham, , United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
Addenbrookes Hospital, Cambridge
Cambridge, , United Kingdom
Noah's Ark Children's Hospital for Wales - Cardiff
Cardiff, , United Kingdom
Royal Hospital for Sick Children - Edinburgh
Edinburgh, , United Kingdom
Royal Hospital for Children Glasgow
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Alder Hey Children's Hospital - Liverpool
Liverpool, , United Kingdom
Great Ormond Street Hospital - London
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Royal Victoria Infirmary, Newcastle
Newcastle, , United Kingdom
Nottingham Children's Hospital
Nottingham, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lisa Törnudd, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/2894
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514917-36-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-001068-31
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.