Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
120
Countries
7
Sites
24
recurrent/progressive medulloblastoma, ependymoma and atypical teratoid rhabdoid tumor (ATRT), rare CNS tumors
To determine the response rate defined as the percentage of patients with CR, PR, SD or lack of recurrence at 6 months after start of antiangiogenic treatment (stratum II, III, V). To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase…
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Oct 2013 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515626-92-00
- EudraCT number
- 2010-023691-33
- ClinicalTrials.gov
- NCT01356290
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety
To determine the response rate defined as the percentage of patients with CR, PR, SD or lack of recurrence at 6 months after start of antiangiogenic treatment (stratum II, III, V).
To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt (stratum IV).
Secondary objectives 7
- To determine the overall survival rate defined as the percentage of patients in the study who are alive at 6, 12, 24, and 36 months after start of treatment.
- To determine the progression free survival rate defined as the percentage of patients in the study who are alive without progressive disease at 6, 12, 24, and 36 months after start of treatment.
- To evaluate and document toxicities from continous administration of these drugs at the doses prescribed in this protocol. These will be descriptive in nature.
- To evaluate quality of life by the KINDL®-questionnaire and PROM in patients capable of participating
- To evaluate the performance status at 6 months after start of treatment with this antiangiogenic multidrug-regimen by applying the Karnofsky performance status in children 12 years of age or older and the Lansky play scale ≥50% in infants and children less than 12 years of age
- To evaluate prognostic factors including tumor biology (histology, molecular group, subgroup, changes in MYC, MYCN, TP53, tumor burden/metastatic stage, age at first diagnosis [<3 years, >3 years]), age at start of antiangiogenic therapy, sex, duration of remission prior to antiangiogenic therapy, number of recurrences. These will be descriptive in nature.
- To evaluate predictive and prognostic markers in blood and CSF.
Conditions and MedDRA coding
recurrent/progressive medulloblastoma, ependymoma and atypical teratoid rhabdoid tumor (ATRT), rare CNS tumors
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Stratum I: Relapsed or progressive medulloblastoma (at least one site of untreated recurrent disease) - completed
- Stratum II: Relapsed or progressive ependymoma (at least one site of untreated recurrent disease)
- Stratum III: Relapsed or progressive ATRT (at least one site of untreated recurrent disease)
- Histological confirmation of medulloblastoma/ependymoma/ATRT at diagnosis or relapse
- Female or male, aged from 0 to <20 years (at time of original diagnosis)
- Participants must have normal organ and bone marrow function (ALT <5x institutional upper limit of normal, creatinine <1.5x institutional upper limit of normal for age, WBC >1000/mm3, platelets > 20,000/mm3. Patients with values less than WBC 2000/mm3 or platelets 50,000/mm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol.
- Karnofsky performance status ≥50. For infants and children less than 12 years of age, the Lansky play scale ≥50% will be used
- Written informed consent of patients and / or parents
- Stratum IV: Relapsed or progressive medulloblastoma (at least one site of untreated recurrent disease)
- Stratum IV: Confirmation of the medulloblastoma group by methylation; IDAT (raw data of methylation array)
- Stratum V: Relapsed or progressive CNS tumor of various histologies or patients with exclusion criteria or adult patients (explorative)
Exclusion criteria 13
- Active infection
- Non-healing surgical wound
- A bone fracture that has not satisfactorily healed
- VP- or subduroperitoneal shunt dependency (can be included in Stratum V)
- Pregnancy or breast feeding
- Treatment for current relapse (surgery may be performed before antiangiogenic treatment; patients with sites of disease not irradiated are still eligible for the protocol)
- Known hypersensitivity to any of the drugs in the protocol
- Active peptic ulcer
- Any significant cardiovascular disease not controlled by standard therapy e.g. systemic hypertension
- Anticipation of the need for major elective surgery during the course of the study treatment
- Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
- Stratum IV: Prior treatment with temozolomide/irinotecan (can be included in Stratum V)
- Previously non-irradiated patients should be evaluated for radiotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- π: probability for response, lack of recurrence after gross total resection. Stratum II+III: H0: π≤15% study therapy is considered as ineffective (type I error rate α=0.05, two sided). H1: π≥35% study therapy is considered as effective (type II error rate β=0.10 in Stratum I, β=0.20 in Stratum II+III). Stratum IV: H0: π1≤ π2 study therapy is considered as equal or inferior (type I error rate α=0.025, one sided). H1: π1>π2 study therapy is consididered as superior (type II error rate β=0.20)
Secondary endpoints 7
- Kaplan Meier survival estimates of overall survival rates after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples
- Kaplan Meier estimates of progression free survival after 6, 12, 24, and 36 months with 95% confidence intervals will be evaluated and compared to historical samples
- The number and relative frequency of toxicities (CTCAE Version 5.0 grade 3, 4 and 5) will be evaluated every 12 weeks.
- Performance status will be compared from the start of therapy and every 12 weeks
- Subscale-scores and total scores of the KINDL assessments at the start of therapy, after 6 months 12 months, 18 months and 24 months of therapy will be evaluated. PRO will be evaluated every two weeks.
- The aforementioned variables will be evaluated comparing their influence on response rate, overall survival rate, progression free survival rate, toxicity, quality of life and performance status by multivariate cox-regression
- Examination of predictive and prognostic factors will be descriptive.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
Temozolomide Accord 5 mg hard capsules.
PRD2640589 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temozolomide Accord 20 mg hard capsules.
PRD2640591 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/005
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Temozolomide Accord 100 mg hard capsules.
PRD2640593 · Product
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AX03 — TEMOZOLOMIDE
- Marketing authorisation
- EU/1/10/615/009
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Etoposid Ebewe 20 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD11150152 · Product
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 9.1 gm/m2 gram(s)/square meter
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- 1-21568
- MA holder
- EBEWE PHARMA
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10004541 · Product
- Active substance
- Celecoxib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 582 g gram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- M01AH01 — CELECOXIB
- Marketing authorisation
- 48802.01.00
- MA holder
- VIATRIS PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Thalidomide 50 mg capsules, hard
PRD10860513 · Product
- Active substance
- Thalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 2100 mg/kg milligram(s)/kilogram
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX02 — THALIDOMIDE
- Marketing authorisation
- PL 17780/1266
- MA holder
- ZENTIVA PHARMA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 520 mg/kg milligram(s)/kilogram
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Irinotecan 20 mg/ml Concentrate for Solution for Infusion
PRD8306592 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — -
- Marketing authorisation
- PL 08828/0299
- MA holder
- FRESENIUS KABI LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eto-GRY® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD3108091 · Product
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- I.T. BOLUS INJECTION TO THE INTRATHECAL SPACE
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- 45891.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cytarabine 100 mg/ml Solution for Injection
PRD1171166 · Product
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- I.T. BOLUS INJECTION TO THE INTRATHECAL SPACE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2.8 g gram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- PA 0822/200/002
- MA holder
- PFIZER HEALTHCARE IRELAND
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide Injection 1 g.
PRD347230 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 36 g gram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 00116/0388
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD1954728 · Product
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- I.T. BOLUS INJECTION TO THE INTRATHECAL SPACE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 1440 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- 44616.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4558929 · Product
- Active substance
- Fenofibrate
- Substance synonyms
- PROPAN-2-YL 2-[4-(4-CHLOROBENZOYL)PHENOXY]-2-METHYLPROPANOATE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 65 gm/m2 gram(s)/square meter
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AB05 — FENOFIBRATE
- Marketing authorisation
- 1-20108
- MA holder
- VIATRIS AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Intensive Care Medicine and Neuropediatrics
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Intensive Care Medicine and Neuropediatrics
Locations
7 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 22 | 5 |
| Czechia | Ongoing, recruiting | 10 | 1 |
| Denmark | Ongoing, recruiting | 8 | 4 |
| France | Ongoing, recruiting | 20 | 4 |
| Norway | Ongoing, recruiting | 5 | 3 |
| Spain | Ongoing, recruiting | 15 | 1 |
| Sweden | Ongoing, recruiting | 20 | 6 |
| Rest of world
United States
|
— | 20 | — |
Investigational sites
Medical University Of Vienna
Division of Neonatology, Intensive Care Medicine and Neuropediatrics, Waehringer Guertel 18-20, Alsergrund, Vienna
Johannes Kepler University Linz
Universitätsklinik für Kinder –u. Jugendheilkunde, MedCampus IV, Krankenhausstrasse 26-30, 4020, Linz
Medizinische Universitaet Innsbruck
Department für Kinder- und Jugendheilkunde, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Klinische Abteilung für Pädiatrische Hämatologie/Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitätsklinik für Kinder –u. Jugendheilkunde, Muellner Hauptstrasse 48, 5020, Salzburg
Rigshospitalet
Department of Paediatric and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
The Hans Christian Andersen Childrens Hospital, J. B. Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Department of Paediatric and Adolescent Medicine, Reberbansgade 15, 9000, Aalborg
Region Midtjylland
Department of Paediatric and Adolescent Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Leon Berard
Centre Leon Berad, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Regional De Marseille
Service d'imunologie, hématologie et oncologie pédiatrique, 144 Rue Saint Pierre, 13005, Marseille
Les Hopitaux Universitaires De Strasbourg
Department of pediatric oncology and hematology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Oscar Lambret
Department of Oncology, Pediatric unit, 3 Rue Frederic Combemale, 59000, Lille
Oslo University Hospital HF
Department of pediatric oncology and hematology, P. O. Box 4950, 0424, Oslo
St. Olavs Hospital HF
Dep. Pediatric oncology and hematology, Prinsesse Kristinas G. 3, 7030, Trondheim
Helse Bergen HF
Onkologisk-hematologisk seksjon, Haukelandsveien 22, 5021, Bergen
Hospital Infantil Universitario Nino Jesus
Department of Pediatric Hematology and Oncology, Avenida Menendez Pelayo 65, 28009, Madrid
Karolinska University Hospital
Astrid Lindgren Children's Hospital, Halsovagen, Flemingsberg, Huddinge
Uppsala University Hospital
Department of Women's and Children's Health, Akademiska Sjukhuset Ingang 86 B16, Pet Centrum, Uppsala
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Childhood cancer centre (ward 322), Behandlingsvagen 7, Harlanda, Gothenburg
Region Oestergoetland
Department of Health, Medicine and Caring Sciences (HMV), Universitetssjukhuset I, 58185, Linkoping
Region Vaesterbotten
Department of Oncology and Hematology, Koksvagen 11, Alidhem, Umea
Region Skane Skanes Universitetssjukhus
Childhood Cancer Research Unit, Entregatan 7, 222 42, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2013-10-18 | 2014-04-09 | |||
| Czechia | 2013-10-18 | 2016-06-06 | |||
| Denmark | 2013-10-18 | 2017-04-25 | |||
| France | 2013-10-18 | 2017-01-23 | |||
| Norway | 2013-10-18 | 2020-10-12 | |||
| Spain | 2013-10-18 | 2019-05-14 | |||
| Sweden | 2013-10-18 | 2018-11-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 182 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 protocol EU CT 2024-515626-92-00_PROTOCOLE_V4 adapte FR_redacted | 4.0 |
| Protocol (for publication) | D1 protocol SM1 EU CT 2024-515626-92-00_redacted | 4.2 |
| Protocol (for publication) | D4 PROMs MEMMAT CZ_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT CZ_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT DE_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT DE_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT DK_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT DK_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT EN_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT EN_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT ES_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT ES_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT FR_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT FR_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT NO_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT NO_3M | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT SE_2W | 1.0 |
| Protocol (for publication) | D4 PROMs MEMMAT SE_3M | 1.0 |
| Protocol (for publication) | D4_Kid_KiddoKINDL_Elternversion_7-17J | NA |
| Protocol (for publication) | D4_Kid_KiddoKINDL_parents_7-17y_Danish | NA |
| Protocol (for publication) | D4_Kid_KiddoKINDL_parents_7-17y_French | NA |
| Protocol (for publication) | D4_Kid_KiddoKINDL_parents_7-17y_Norwegian | NA |
| Protocol (for publication) | D4_Kid_KiddoKINDL_parents_7-17y_Spanish | NA |
| Protocol (for publication) | D4_Kid_KiddoKINDL_parents_7-17y_Swedish | NA |
| Protocol (for publication) | D4_KiddoKINDL_adolescents_14-17y_Danish | NA |
| Protocol (for publication) | D4_KiddoKINDL_adolescents_14-17y_French | NA |
| Protocol (for publication) | D4_KiddoKINDL_adolescents_14-17y_Norwegian | NA |
| Protocol (for publication) | D4_KiddoKINDL_adolescents_14-17y_Spanish | NA |
| Protocol (for publication) | D4_KiddoKINDL_adolescents_14-17y_Swedish | NA |
| Protocol (for publication) | D4_KiddoKINDL_Jugendversion_14-17J | NA |
| Protocol (for publication) | D4_KiddyKINDL_children_4-6y_CZ | NA |
| Protocol (for publication) | D4_KiddyKINDL_children_4-6y_French | NA |
| Protocol (for publication) | D4_KiddyKINDL_children_4-6y_Norwegian | NA |
| Protocol (for publication) | D4_KiddyKINDL_children_4-6y_Spanish | NA |
| Protocol (for publication) | D4_KiddyKINDL_children_4-6y_Swedish | NA |
| Protocol (for publication) | D4_KiddyKINDL_Elternversion_3-6J | NA |
| Protocol (for publication) | D4_KiddyKINDL_Kinderversion_4-6J | NA |
| Protocol (for publication) | D4_KiddyKINDL_parents_3-6y_CZ | NA |
| Protocol (for publication) | D4_KiddyKINDL_parents_3-6y_French | NA |
| Protocol (for publication) | D4_KiddyKINDL_parents_3-6y_Norwegian | NA |
| Protocol (for publication) | D4_KiddyKINDL_parents_3-6y_Spanish | NA |
| Protocol (for publication) | D4_KiddyKINDL_parents_3-6y_Swedish | NA |
| Protocol (for publication) | D4_KidKINDL_children_7-13y_Danish | NA |
| Protocol (for publication) | D4_KidKINDL_children_7-13y_French | NA |
| Protocol (for publication) | D4_KidKINDL_children_7-13y_Norwegian | NA |
| Protocol (for publication) | D4_KidKINDL_children_7-13y_Spanish | NA |
| Protocol (for publication) | D4_KidKINDL_children_7-13y_Swedish | NA |
| Protocol (for publication) | D4_KidKINDL_Kinderversion_7-13J | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment_aggrements_EU_CT_ 2024-515626-92-00_SE | 30/05/2023 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedue_Brno_CZ | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure_AT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_ES | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure_FR | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure_NO | 1.0 |
| Recruitment arrangements (for publication) | Placeholder 1_EU CT 2024-515626-92-00 | NA |
| Subject information and informed consent form (for publication) | D4 ICF adolescent_french | 3.0 |
| Subject information and informed consent form (for publication) | D4 ICF adults_french | 4.0 |
| Subject information and informed consent form (for publication) | D4 ICF Enfants_french | 3.0 |
| Subject information and informed consent form (for publication) | D4 ICF Etude optionnelle Parents_french | 3.0 |
| Subject information and informed consent form (for publication) | D4 ICF Etude optionnelle Parents_french_redacted | 3.0 |
| Subject information and informed consent form (for publication) | D4 ICF Etude optionnelle_french | 4.0 |
| Subject information and informed consent form (for publication) | D4 ICF Etude optionnelle_french_redacted | 4.0 |
| Subject information and informed consent form (for publication) | D4 ICF Parents_french | 3.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 2 15-17_czech | 1.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 2 18_czech | 1.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 2 parent | 1 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 3 12-14_czech | 1.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 3 15-17_czech | 1.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 3 18_czech | 1.0 |
| Subject information and informed consent form (for publication) | D4 ICF stratum 3 parent | 1.0 |
| Subject information and informed consent form (for publication) | D4_ICF parent_spanish | 1.8 |
| Subject information and informed consent form (for publication) | D4_ICF parent_swedish | 3 |
| Subject information and informed consent form (for publication) | D4_ICF patient 12-14_swedish | 3 |
| Subject information and informed consent form (for publication) | D4_ICF patient 12-17_spanish | 1.8 |
| Subject information and informed consent form (for publication) | D4_ICF patient 15-18_swedish | 3 |
| Subject information and informed consent form (for publication) | D4_ICF patient 18+_spanish | 1.8 |
| Subject information and informed consent form (for publication) | D4_ICF patient_6-11_swedish | 3 |
| Subject information and informed consent form (for publication) | L1 ICF adolescent_french_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 ICF adults_french_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1 ICF Enfants_french_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 ICF Parents_french_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 2 18_czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 2 parent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 3 12-14_czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 3 15-17_czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 3 18_czech_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 ICF stratum 3 parent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1 participant information 15-17_danish_redacted | NA |
| Subject information and informed consent form (for publication) | L1 participant information adult_danish_redacted | NA |
| Subject information and informed consent form (for publication) | L1 participant information parents_danish_redacted | NA |
| Subject information and informed consent form (for publication) | L1_Dine rettigheder som forsgsperson i forsg med medicin _ De Videnskabsetiske Komiteer | NA |
| Subject information and informed consent form (for publication) | L1_HIPCI_12-17_ES_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_HIPCI_18+_ES_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_HIPCI_Padres_ES_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF vardnadshavare_ependymom-ATRT-sallsynta_swedish_redacted | NA |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_adolescents_Master AT_en_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_children_Master AT_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_parents_Master AT_en_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_v2_1_adolescents_Master AT_en_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_v2_1_children_Master AT_en | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_v2_1_parents_Master AT_en_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_v2_2_adolescents_Master AT_en | 2.2 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_EP_ATRT_rare_v2_2_parents_Master AT_en | 2.2 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_adolescents_Master AT_en_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_children_Master AT_en | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_parents_Master AT_en_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_v2_1_adolescents_Master AT_en_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_v2_1_children_Master AT_en | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_v2_1_parents_Master AT_en_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_v2_2_adolescents_Master AT_en | 2.2 |
| Subject information and informed consent form (for publication) | L1_ICF_MEMMAT_medulloblastoma_v2_2_parents_Master AT_en | 2.2 |
| Subject information and informed consent form (for publication) | L1_ICF_res ep-ATRT-sjeldne CNS_12-18 ar_redacted_NO | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF_res ep-ATRT-SjeldneCNS_18 ar_redacted_NO | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_res EP-ATRT-sjeldneCNS_barn12ar_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_res ep-ATRT-sjeldneCNS_foreldre_redacted_NO | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_resMB_12-18ar_redacted_NO | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF_resMB_barn12ar_clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_resMB_foreldre_redacted_NO | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF_resMB_voksne18ar_redacted_NO | 5.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 12-14 let_EPEND_stratum II_v2_clean_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 12-14 let_MED_stratum IV_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 12-14 let_rare CNS_stratum V_v1_clean_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 15-17 let_EPEND_stratum II_v2_clean_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 15-17 let_MED_stratum IV_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS 15-17 let_rare CNS_stratum V_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS nad 18 let_MED_stratum IV_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS nad 18 let_rare CNS_stratum V_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS rodice_MED_stratum IV_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_IS rodice_rare CNS_stratum V_v1_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_NIFC_strate 4_Adolescents_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_NIFC_strate 4_Enfants_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_NIFC_strate 4_Majeurs_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_MEMMAT_NIFC_strate 4_Parents_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_EP-ATRT-rare_Eltern_MASTER AT_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_EP-ATRT-rare_Kinder_MASTER AT | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_Medulloblastom_Jugendliche_MASTER AT_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_Medulloblastom_Kinder_Master AT | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Eltern_v2_1_MASTER AT_de_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Eltern_v2_2_MASTER AT_de | 2.2 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Jugendliche_v2_0_MASTER AT_de_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Jugendliche_v2_1_MASTER AT_de_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Jugendliche_v2_2_MASTER AT_de | 2.2 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_EP-ATRT-rare_Kinder_v2_1_MASTER AT_de | 2.1 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Eltern_v2_0_Master AT_de_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Eltern_v2_1_Master AT_de_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Eltern_v2_2_Master AT_de | 2.2 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Jugendliche_v2_1_Master AT_de_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Jugendliche_v2_2_Master AT_de | 2.2 |
| Subject information and informed consent form (for publication) | L1_Patienteneinwilligungserklarung_MEMMAT_Medulloblastom_Kinder_v2_1_Master AT_de | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_ 12-14 ar_ependymom-ATRT-sallsynta_redacted_SE | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_ 12-14 ar_stratum IV_redacted_SE | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_ 15-18 ar_ependymom-ATRT-sallsynta_redacted_SE | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_ 15-18 ar_stratum IV_redacted_SE | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_6-11 ar_ependymom-ATRT-sallsynta_clean_SE | 09/04/2025 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_6-11 ar_Stratum IV_Clean_SE | 09/04/2025 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_vardnadshavare_STRATUM IV_redacted_SE | NA |
| Subject information and informed consent form (for publication) | L1_SIS_MEMMAT all tumours_10-14 yr_danish | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_MEMMAT all tumours_5-9 yr_danish | 1.0 |
| Subject information and informed consent form (for publication) | L2_MEMMAT_Carnet parents_V1_irinotecan-temozolomide | 1.0 |
| Subject information and informed consent form (for publication) | L2_MEMMAT_Carnet parents_V3_cyclophosphamide-etoposide | 1.0 |
| Subject information and informed consent form (for publication) | L2_MEMMAT_Carnet patients majeurs_V1_irinotecan-temozolomide | 1.0 |
| Subject information and informed consent form (for publication) | L2_MEMMAT_Carnet patients majeurs_V3_cyclophosphamide-etoposide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patienteneinwilligungserklarung_AT_Zentrumsspezifische Informationen | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Avastin 25mgml concentrate for solution for infusion | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Celebrex 200 mg capsule | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cyclophosphamide Injection 1 g | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabin | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine Injection BP 100 mgml | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Eto-GRY 20 mgml Konzentrat zur Herstellung einer Infusionslosung | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Irinotecan 20mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Smpc_Irinotecan 20mg_AT | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lipcor 200mg | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmpC_temozolomide_en | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Thalidomide BMS 50 mg Hard Capsules | 1 |
| Synopsis of the protocol (for publication) | D1 protocol synopsis EUCT 24-515626-92-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1 protocol synopsis SM1 EUCT 24-515626-92-00 | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SM1 AT 2024-515626-92-00 | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SM1 ES 2024-515626-92-00 | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SM1_CZ_2024-515626-92-00 | 3.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SM1_FR_2024-515626-92-00_clean | 6.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SM1_NO_2024-515626-92-00 | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SM1_SE_2024-515626-92-00 | 4.2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-03 | Austria | Acceptable 2024-10-09
|
2024-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-19 | Austria | Acceptable 2025-11-24
|
2025-11-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-25 | Acceptable 2025-11-24
|
2026-03-25 |