Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
280
Countries
1
Sites
29
low and intermediate risk neuroblastoma
Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by gene expression based risk stratification.
Key facts
- Sponsor
- University Of Cologne
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Deutsche Kinderkrebs-Stiftung
External identifiers
- EU CT number
- 2024-517295-37-00
- EudraCT number
- 2017-004883-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Improvement of event free survival (EFS) of patients with intensified treatment and no impairment of EFS of patients with reduced treatment after treatment allocation by gene expression based risk
stratification.
Secondary objectives 1
- Implementation of a RNA expression based classifier for the risk prediction of low- and intermediate risk neuroblastoma patients.
Conditions and MedDRA coding
low and intermediate risk neuroblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029260 | Neuroblastoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Neuroblastoma diagnosed according to the accepted criteria: histological diagnosis from tumor tissue or presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
- MYCN not amplified
- Stage and age either: a. localized neuroblastoma INRGSS stage L1/L2/INSS stage 1-3 and age at diagnosis ≥18 months and < 21 years b. INSS Stage 4S/INRGSS stage MS c. INSS Stage 4/INRGSS stage M and age at diagnosis <18 months d. INRGSS stage L1/L2 and age at first diagnosis <18 months with relapse or progression of neuroblastoma
- Sufficient tumor tissue available from initial diagnosis available for analysis of RNA expression array
- Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development
Exclusion criteria 12
- Participation in other clinical trials
- Pregnancy or lactation
- Insufficient contraception for sexually active study participants as well as female partners of sexually active male trial participants. Patients must be informed about the need of adequate contraception. Moreover, this need for contraception must be understood by the trial participants. Only contraception with a Pearl index <1% are considered as sufficient. For the purpose of this trial, these are long-term parenteral hormones, progesterone releasing implants, intramuscular progesterone, and intrauterine hormone releasing devices, tubal ligation, and vaginal hormonal contraception. This also holds true for adolescents who are at risk to become sexually active during trial participation
- Any concomitant non-protocol anticancer therapy
- Incomplete initial staging
- Known allergy/hypersensitivity to the scheduled drugs
- Impaired cardiac function such as insufficiency, heart rate abnormalities and blood pressure abnormalities corresponding to CTCAE 5.0 grade 2 or higher. Hypertension according to age specific reference values clearly due to neuroblastoma is no exclusion criterion
- Impaired renal function defined by a reduced glomerular filtration rate <30 ml/min*1,73 m2 determined by serum creatinine (Schwartz formula) or serum cystatin C
- Impaired liver function corresponding to CTCAE 5.0 grade 3 or higher unless liver impairment is clearly caused by neuroblastoma in stage 4S/MS patients. Isolated elevation of the transaminases without evidence of impaired liver function is not an exclusion criterion
- History of earlier VOD/SOS of the liver
- Impaired bone marrow function defined by granulocytes <500/μl and/or thrombocytes <50.000/μl unless clearly caused by bone marrow involvement proven by bone marrow cytology or diffuse abnormal osteomedullary signal in the mIBG scintigraphy
- HIV infection because of the antiretroviral medication which potentially interferes with the metabolism of the scheduled investigational drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease
Secondary endpoints 7
- Overall Survival (OS): Because of the importance for the individual patient OS has been chosen as secondary endpoint.
- Risk factors to impact on EFS and OS: The risk factors age at diagnosis, stage according to INSS and INRG, and copy number alterations of selected genes have been implemented in the INRG classification. These factors will be assessed by multivariate and subgroup analysis. Moreover, the description of patients’ cohorts by these risk factors is mandatory for international comparison of the trial results.
- Response: In neuroblastoma, response to trial treatment is not clearly correlated to outcome. In this trial, response to trial treatment will be compared to historical controls, with a special focus to the cohort with reduced treatment (group C).
- Regression: The percentage of spontaneous regression will be described in patients where the residual primary is observed without cytotoxic treatment and compared to historical controls.
- Incidence rates of toxic events: The administered chemotherapy cycles are known to cause treatment related side effects. To estimate the burden for the patients, kind and intensity of side effects will be compared to historical controls and between the patient groups A-C.
- Additional molecular analysis: The impact of clinical and molecular risk factors such as copy number alterations, telomere maintenance status and mutation status of candidate genes on EFS and OS will be analyzed.
- Group D, relapsed patients: Outcome of patients with relapse or progression of neuroblastoma diagnosed at the age < 18 months with unfavorable classification.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
SUB06882MIG · Substance
- Active substance
- Dacarbazine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 300 mg/m2 milligram(s)/square meter
- Max total dose
- 8400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/square meter
- Max total dose
- 4800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 32 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05102MIG · Substance
- Active substance
- Vindesine Sulfate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 mg/m2 milligram(s)/square meter
- Max total dose
- 9 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 160 mg/m2 milligram(s)/square meter
- Max total dose
- 640 mg/m2 milligram(s)/square meter
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05993MIG · Substance
- Active substance
- Busulfan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 4.8 mg/kg milligram(s)/kilogram
- Max total dose
- 19.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB174757 · Substance
- Active substance
- Dinutuximab Beta
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/m2 milligram(s)/square meter
- Max total dose
- 5000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 50 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/12/1062
- Modified vs. Marketing Authorisation
- No
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 180 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13772MIG · Substance
- Active substance
- Etoposide Phosphate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 1200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08125MIG · Substance
- Active substance
- Ifosfamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1500 mg/m2 milligram(s)/square meter
- Max total dose
- 22500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 480 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 1200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08728MIG · Substance
- Active substance
- Melphalan
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 140 mg/m2 milligram(s)/square meter
- Max total dose
- 140 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1.5 mg/m2 milligram(s)/square meter
- Max total dose
- 9 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
SUB02888MIG · Substance
- Active substance
- Lenograstim
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 µg/Kg microgram(s)/kilogram
- Max total dose
- 400 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 70 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08784MIG · Substance
- Active substance
- Mesna
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 900 mg/m2 milligram(s)/square meter
- Max total dose
- 18900 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06728MIG · Substance
- Active substance
- Clonazepam
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.1 mg/kg milligram(s)/kilogram
- Max total dose
- 0.7 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07627MIG · Substance
- Active substance
- Filgrastim
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 µg/Kg microgram(s)/kilogram
- Max total dose
- 400 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 70 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Cologne
- Sponsor organisation
- University Of Cologne
- Address
- Albertus-Magnus-Platz 1
- City
- Cologne
- Postcode
- 50923
- Country
- Germany
Scientific contact point
- Organisation
- University Of Cologne
- Contact name
- Clinical trial coordinator
Public contact point
- Organisation
- University Of Cologne
- Contact name
- Clinical trial coordinator
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts ORG-100009395
|
Heidelberg, Germany | Other |
| Prinses Maxima Centrum voor Kinderoncologie B.V. ORG-100011005
|
Utrecht, Netherlands | Laboratory analysis |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | Other, Laboratory analysis |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | Other, Laboratory analysis |
| Universitaetsklinikum Tuebingen AöR ORG-100007980
|
Tuebingen, Germany | Other |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | Other, Laboratory analysis |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | On site monitoring, Code 8 |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | Other |
| University Hospital Cologne AöR ORG-100012761
|
Cologne, Germany | Other |
| Charite Universitaetsmedizin Berlin KöR ORG-100008480
|
Berlin, Germany | Other |
| Universitaetsklinikum Bonn AöR ORG-100009711
|
Bonn, Germany | Other, Laboratory analysis |
| Universitaet Muenster ORG-100008258
|
Muenster, Germany | Code 10 |
Locations
1 EU/EEA country · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 280 | 29 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Cologne AöR
Pediatric Oncology, Kerpener Strasse 62, Lindenthal, Cologne
Kliniken der Stadt Koeln gGmbH
Kinderkrankenhaus, Amsterdamer Strasse 59, Riehl, Cologne
Universitaet Muenster
Klinik für Kinder- und Jugendmedizin Paediatrische Haematologie und Onkologie, Albert-Schweitzer-Strasse 33, 48149, Muenster
Universitaetsklinikum Regensburg AöR
Dept. of Paediatric Haematology, Oncology and Stem Cell Transplantation, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Erlangen AöR
Kinder- und Jugendklinik, Abteilung für Päd. Onkologie und Hämatologie, Loschgestrasse 15, Innenstadt, Erlangen
Universitaetsklinikum Bonn AöR
Zentrum für Kinder- und Jugendmedizin Abt. Päd. Hämatologie/Onkologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Giessen und Marburg GmbH
Pediatric Hematology, Oncology & Immunodeficiencies, Feulgenstrasse 10-12, 35392, Giessen
Universitaetsmedizin Goettingen
Clinic for Pediatric and Adolescent Medicine, Pediatric Hematology and Oncology, Robert-Koch-Strasse 40, Weende, Goettingen
Klinikum Dortmund gGmbH
Klinik für Kinder- und Jugendmedizin, Beurhausstrasse 40, Mitte, Dortmund
Technische Universitaet Dresden
Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Asklepios Klinik Sankt Augustin GmbH
Pädiatrische Onkologie und Hämatologie, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Otto Von Guericke Universitaet Magdeburg
Abt. Pädiatrische Hämatologie und Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Universitaetsklinikum Augsburg
Klinik für Kinder- und Jugendmedizin Schwäbisches Kinderkrebszentrum, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Mannheim GmbH
Kinderonkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Pädiatrie 5 (Onkologie, Hämatologie, Immunologie), Kriegsbergstrasse 62, Mitte, Stuttgart
Universitaetsklinikum Aachen AöR
Päd. Hämatologie, Onkologie u. SZT, Pauwelsstrasse 30, 52074, Aachen
HELIOS Klinikum Krefeld GmbH
Zentrum für Kinder- und Jugendmedizin Abt. für Hämatologie und Onkologie, Lutherplatz 40, Diessem/lehmheide, Krefeld
Charite Universitaetsmedizin Berlin KöR
Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie, Augustenburger Platz 1, Wedding, Berlin
Universitaet Leipzig
Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Klinikum Kassel GmbH
Klinik für päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen, Moenchebergstrasse 41-43, Fasanenhof, Kassel
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Kinder- und Jugendmedizin, Päd. Onkologie/Hämatologie, Schwanebecker Chaussee 50, Buch, Berlin
HELIOS Klinikum Erfurt GmbH
Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Universitaetsklinikum Jena KöR
Klinik für Kinder- und Jugendmedizin, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik und Poliklinik für Kinder- und Jugendmedizin Kinderonkologisches Zentrum, Langenbeckstrasse 1, Oberstadt, Mainz
Staedtisches Klinikum Karlsruhe gGmbH
Franz Lust Kinderklinik Pädiatrische Hämatologie und Onkologie, Moltkestrasse 90, Weststadt, Karlsruhe
Gesundheit Nord gGmbH Klinikverbund Bremen
Klinikum Bremen-Mitte, Eltern-Kind-Zentrum Prof. Hess, Kinderonkologie-Station 3, St.-Juergen-Strasse 1, Hulsberg, Bremen
Universitaetsklinikum Wuerzburg AöR
Universitätskinderklinik, Hämatologie und Onkologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Evangelisches Klinikum Bethel gGmbH
Campus Bielefeld-Bethel, Hämatologie/Onkologie, Grenzweg 14, Gadderbaum, Bielefeld
Martin-Luther-Universitaet Halle-Wittenberg
Klinik Pädiatrie I für Pädiatrische Onkologie, Hämatologie, Rheumatologie und Immunologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517295-37-00_p | 1 |
| Recruitment arrangements (for publication) | Placeholder_not required_2024-517295-37-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adolescent_p | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_p | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and PIC child | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and PIC custodial_p | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Busulfan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cyclophosphamid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dacarbacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dinutuximab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Doxorubicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Etoposid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Etoposidphosphat | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Ifosfamid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Melphalan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Vincristin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Vindesin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Germany | Acceptable 2024-10-24
|
2024-10-25 |