Treatment of infants under one year with acute lymphoblastic leukemia according to the Interfant-21 protocol

2022-502503-30-00 Protocol SP-MH20INT Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 15 Dec 2022 · Status Authorised, recruiting · 19 EU/EEA countries · 135 sites · Protocol SP-MH20INT

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 264
Countries 19
Sites 135

Acute lymphoblastic leukemia

To improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2Arearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the Interfant06 protocol.

Key facts

Sponsor
Princess Maxima Center For Pediatric Oncology
Participant type
Pediatric, Patients
Age range
0-17 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
15 Dec 2022 → ongoing
Decision date (initial)
2023-06-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Amgen Europe B.V.

External identifiers

EU CT number
2022-502503-30-00
EudraCT number
2021-000213-16
ClinicalTrials.gov
NCT05327894

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2Arearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the Interfant06 protocol.

Secondary objectives 9

  1. To estimate overall survival (OS) and compare it with corresponding historical results of the Interfant-06 protocol, in the whole study and by risk group.
  2. To determine outcome (in terms of secondary endpoint 2) according to risk group and compare it with corresponding historical results of the Interfant-06 protocol.
  3. To determine outcome (in terms of secondary endpoint 3) taking into account the protocol-specific definition of resistance.
  4. To assess the response to different treatment phases in term of minimal residual disease (MRD) response.
  5. To evaluate the incidence of CD19 negative relapses
  6. To evaluate the incidence of myeloid lineage switches
  7. To describe the toxicity associated to each treatment phase.
  8. To describe long term cardiotoxicity
  9. To evaluate survival after relapse, overall and by risk group

Conditions and MedDRA coding

Acute lymphoblastic leukemia

VersionLevelCodeTermSystem organ class
21.0 LLT 10000845 Acute lymphoblastic leukemia 10029104

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2016-004674-17 A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network. , Pilotní studie testující proveditelnost, bezpečnost a účinnost přidání BiTE protilátky blinatumomab do léčebného protokolu Interfant-06 u kojenců s akutní lymfoblastickou leukémií s přestavbou genu MLL. , Studio pilota per valutare la fattibilità, la sicurezza e l’efficacia dell’aggiunta dell’anticorpo BiTE Blinatumomab alla chemioterapia del protocollo Interfant-06 in pazienti con Leucemia Linfoblastica Acuta MLL-riarrangiata di età inferiore a 1 anno.
2005-004599-19 INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR INFANTS UNDER ONE YEAR WITH ACUTE LYMPHOBLASTIC OR BIPHENOTYPIC LEUKEMIA, Protocollo collaborativo internazionale di terapia per i bambini di eta' inferiore ad 1 anno affetti da Leucemia Acuta Linfoide o Bifenotipica, INTERFANT 06 - International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
  2. ≤ 365 days of age at the time of diagnosis of ALL.
  3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.

Exclusion criteria 11

  1. KMT2A-wildtype patients.
  2. Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
  3. T-ALL.
  4. Age > 365 days at the time of diagnosis.
  5. Relapsed ALL.
  6. Additional exclusion criteria for blinatumomab: 1. CD19 negative B-precursor ALL at diagnosis
  7. Additional exclusion criteria for blinatumomab: 2. CNS involvement (CNS2/CNS3/TLP+ status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of induction).
  8. Additional exclusion criteria for blinatumomab: 3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
  9. Additional exclusion criteria for blinatumomab: 4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to Bcell recovery after the last dose of blinatumomab.
  10. Down syndrome
  11. Multilineage MPAL

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. EFS defined as the time from diagnosis to resistance to induction (i.e. no complete remission at the end of induction) , relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.

Secondary endpoints 9

  1. OS is defined as the time from the date of diagnosis to death from any cause. Patients who are alive will be censored at the date of last follow up. OS will be estimated for the entire study cohort and according to risk group.
  2. The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction (no complete remission at the end of induction) , cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
  3. Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.
  4. MRD response as defined in the protocol and frequencies of MRD levels.
  5. Proportion of CD19 negative relapses in the entire study cohort and according to risk group.
  6. Proportion of myeloid lineage switches in the entire study cohort and according to risk group.
  7. Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases.
  8. Proportion of grade ≥2 cardiac disorders (See AESI Table in protocol) at 2 and 5 years after diagnosis
  9. OS after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion

PRD3418637 · Product

Active substance
Blinatumomab
Substance synonyms
MT-103, MEDI-538, MT103, Recombinant antibody derivative against human CD19 and CD3
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
15 µg/ m2 microgram(s)/ sq. Meter
Max total dose
840 µg/ m2 microgram(s)/ sq. Meter
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
L01FX07 — -
Marketing authorisation
EU/1/15/1047/001
MA holder
AMGEN EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/09/650
Modified vs. Marketing Authorisation
No

Auxiliary 22

Spectrila 10,000 U powder for concentrate for solution for infusion

PRD3615228 · Product

Active substance
Asparaginase
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1500 IU international unit(s)
Max total dose
6000 IU international unit(s)
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01XX02 — ASPARAGINASE
Marketing authorisation
EU/1/15/1072/001
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Spectrila 10,000 U powder for concentrate for solution for infusion

PRD3615229 · Product

Active substance
Asparaginase
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1500 IU international unit(s)
Max total dose
6000 IU international unit(s)
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01XX02 — ASPARAGINASE
Marketing authorisation
EU/1/15/1072/002
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cerubidine 20 mg, poeder en oplosmiddel voor oplossing voor injectie

PRD522648 · Product

Active substance
Daunorubicin
Substance synonyms
DAUNOMYCIN, RUBIDOMYCIN
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
75 mg/m2 milligram(s)/square meter
Max total dose
2250 mg/m2 milligram(s)/square meter
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
L01DB02 — DAUNORUBICIN
Marketing authorisation
RVG 05633
MA holder
GENZYME EUROPE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Prednison Auro 5 mg, tabletten

PRD679922 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
420 mg/m2 milligram(s)/square meter
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
RVG 52249
MA holder
AUROBINDO PHARMA B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Cortef Powder for Solution for Injection or Infusion 100 mg

PRD1179840 · Product

Active substance
Hydrocortisone
Substance synonyms
CORTISOL
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
20 mg milligram(s)
Max total dose
400 mg milligram(s)
Max treatment duration
20 Day(s)
Authorisation status
Authorised
ATC code
H02AB09 — HYDROCORTISONE
Marketing authorisation
PA 0822/137/001
MA holder
PFIZER HEALTHCARE IRELAND
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ENDOXAN I.V., poeder voor oplossing voor injectie (lyofilisaat) 1000 mg

PRD3123827 · Product

Active substance
Cyclophosphamide Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
1000 mg/m2 milligram(s)/square meter
Max total dose
3000 mg/m2 milligram(s)/square meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation
RVG 08058
MA holder
BAXTER B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ENDOXAN I.V., poeder voor oplossing voor injectie (lyofilisaat) 500 mg

PRD3123825 · Product

Active substance
Cyclophosphamide Monohydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
1000 mg/m2 milligram(s)/square meter
Max total dose
3000 mg/m2 milligram(s)/square meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation
RVG 08058
MA holder
BAXTER B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Toposin, concentraat voor oplossing voor intraveneuze infusie 20 mg/ml

PRD667434 · Product

Active substance
Etoposide
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS
Max daily dose
100 mg/m2 milligram(s)/square meter
Max total dose
500 mg/m2 milligram(s)/square meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
L01CB01 — ETOPOSIDE
Marketing authorisation
RVG 16010
MA holder
TEVA B.V
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xaluprine 20 mg/ml oral suspension

PRD2661282 · Product

Active substance
Mercaptopurine
Pharmaceutical form
ORAL SUSPENSION
Route of administration
ORAL
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
29330 mg/m2 milligram(s)/square meter
Max treatment duration
84 Week(s)
Authorisation status
Authorised
ATC code
L01BB02 — MERCAPTOPURINE
Marketing authorisation
EU/1/11/727/001
MA holder
NOVA LABORATORIES IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine Accord 100 mg/ml, oplossing voor injectie of infusie

PRD869088 · Product

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
6000 mg/m2 milligram(s)/square meter
Max total dose
22850 mg/m2 milligram(s)/sq. meter
Max treatment duration
51 Day(s)
Authorisation status
Authorised
ATC code
L01BC01 — CYTARABINE
Marketing authorisation
RVG 112666
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethason Teva 1,5 mg, tabletten

PRD555280 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
6 mg/m2 milligram(s)/square meter
Max total dose
126 mg/m2 milligram(s)/square meter
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
RVG 56080
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone phosphate 4 mg/ml solution for injection

PRD9179428 · Product

Active substance
Dexamethasone Sodium Phosphate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0.4 mg/Kg milligram(s)/kilogram
Max total dose
2.8 mg/kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
PA2237/004/001
MA holder
HAMELN PHARMA GMBH
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone 10mg/5ml Oral Solution

PRD8867417 · Product

Active substance
Dexamethasone
Pharmaceutical form
ORAL SOLUTION
Route of administration
ORAL
Max daily dose
0.4 mg/kg milligram(s)/kilogram
Max total dose
2.8 mg/kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
PA23081/007/001
MA holder
TAW PHARMA (IRELAND) LTD
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethason Teva 0,5 mg, tabletten

PRD553702 · Product

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
6 mg/m2 milligram(s)/square meter
Max total dose
126 mg/m2 milligram(s)/square meter
Max treatment duration
21 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
RVG 56079
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial.

PRD1179849 · Product

Active substance
Methylprednisolone
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
4 mg milligram(s)
Max total dose
80 mg milligram(s)
Max treatment duration
20 Day(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
PA 0822/136/004
MA holder
PFIZER HEALTHCARE IRELAND
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Thiosix 10 mg, tabletten

PRD3169320 · Product

Active substance
Tioguanine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
1680 mg/m2 milligram(s)/square meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
L01BB03 — TIOGUANINE
Marketing authorisation
RVG 114680
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Thiosix 20 mg, tabletten

PRD3169623 · Product

Active substance
Tioguanine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
1680 mg/m2 milligram(s)/square meter
Max treatment duration
28 Day(s)
Authorisation status
Authorised
ATC code
L01BB03 — TIOGUANINE
Marketing authorisation
RVG 114681
MA holder
TEVA NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Emthexate PF 100 mg/ml, oplossing voor injectie

PRD667598 · Product

Active substance
Methotrexate
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS
Max daily dose
5000 mg/m2 milligram(s)/square meter
Max total dose
10000 mg/m2 milligram(s)/square meter
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L01BA01 — METHOTREXATE
Marketing authorisation
RVG 10632
MA holder
TEVA B.V
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexaat Teva 10 mg, tabletten

PRD687826 · Product

Active substance
Methotrexate
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
20 mg/m2 milligram(s)/square meter
Max total dose
1560 mg/m2 milligram(s)/square meter
Max treatment duration
78 Week(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
RVG 08785
MA holder
TEVA B.V
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexaat Teva 2,5 mg, tabletten

PRD687789 · Product

Active substance
Methotrexate
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
20 mg/m2 milligram(s)/square meter
Max total dose
1560 mg/m2 milligram(s)/square meter
Max treatment duration
78 Week(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
RVG 09957
MA holder
TEVA B.V
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mitoxantron Sandoz 2 mg/ml, concentraat voor oplossing voor infusie

PRD768852 · Product

Active substance
Mitoxantrone
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
12 mg/m2 milligram(s)/square meter
Max total dose
36 mg/m2 milligram(s)/square meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01DB07 — MITOXANTRONE
Marketing authorisation
RVG 29568
MA holder
SANDOZ B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristinesulfaat Teva 1 mg/ml, oplossing voor injectie

PRD667758 · Product

Active substance
Vincristine Sulfate
Pharmaceutical form
INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0.05 mg/kg milligram(s)/kilogram
Max total dose
0.20 mg/kg milligram(s)/kilogram
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
RVG 100081
MA holder
TEVA B.V
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Princess Maxima Center For Pediatric Oncology

5 Total trials 5 Recruiting
Academic / Non-commercial
Sponsor organisation
Princess Maxima Center For Pediatric Oncology
Address
Heidelberglaan 25
City
Utrecht
Postcode
3584 CS
Country
Netherlands

Scientific contact point

Organisation
Princess Maxima Center For Pediatric Oncology
Contact name
J Stutterheim

Public contact point

Organisation
Princess Maxima Center For Pediatric Oncology
Contact name
Secretariat TDC

Third parties 1

OrganisationCity, countryDuties
Coronis Research S.A.
ORG-100028085
 Chalandri, Greece On site monitoring, Code 12, Other, Code 5

Sponsor responsibilities

Article 77 compliance
Princess Maxima Center For Pediatric Oncology
Contact point sponsor
Princess Maxima Center For Pediatric Oncology
Article 77 implementation
Princess Maxima Center For Pediatric Oncology

Locations

19 EU/EEA countries · 135 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 12 5
Belgium Temporarily halted 9 7
Czechia Ongoing, recruiting 6 3
Denmark Ongoing, recruiting 6 3
Finland Ongoing, recruiting 6 5
France Ongoing, recruiting 24 20
Germany Ongoing, recruiting 33 25
Greece Authorised, recruiting 3 7
Hungary Ongoing, recruiting 6 2
Ireland Ongoing, recruiting 3 1
Italy Ongoing, recruiting 24 21
Lithuania Temporarily halted 3 1
Netherlands Ongoing, recruiting 12 1
Norway Authorised, recruiting 5 4
Poland Ended 20 16
Portugal Temporarily halted 6 3
Slovakia Temporarily halted 3 1
Spain Ongoing, recruiting 20 4
Sweden Ongoing, recruiting 9 6
Rest of world
New Zealand, Australia, Israel, Chile, Brazil, Argentina, Switzerland, Japan, Saudi Arabia
 — 54 —

Investigational sites

Austria

5 sites · Ongoing, recruitment ended
Medical University Of Graz
Dept. of Pediatric and Adolescent Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
Pediatrics, Anichstrasse 35, 6020, Innsbruck
St. Anna Childrens Cancer Research Institute GmbH
Studies & Statistics for Integrated Research and Projects Projects –- S²IRP, Zimmermannplatz 10, Alsergrund, Vienna
St. Anna Kinderspital GmbH
Pediatric Hematology and Oncology 2A, Kinderspitalgasse 6, Alsergrund, Vienna
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
UK fur Kinder-und Jugendheilkunde der PMU Salzburg, Landeskrankenhaus, Muellner Hauptstrasse 48, 5020, Salzburg

Belgium

7 sites · Temporarily halted
CHC MontLegia
Pediatric Hemato-Oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Universitair Ziekenhuis Gent
Pediatric Hemato-Oncology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Pediatric Hemato-Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Pediatric Hemato-Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Regional De La Citadelle
Pediatric Hemato-Oncology, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Pediatric Hemato-Oncology, Jean Joseph Crocqlaan 15, 1020, Brussels
Antwerp University Hospital
Pediatric Hemato-Oncology, Drie Eikenstraat 655, 2650, Edegem

Czechia

3 sites · Ongoing, recruiting
Fakultni Nemocnice Brno
Klinika detske onkologie, Cernopolni 9, Cerna Pole, Brno-Sever
University Hospital Olomouc
Dětská klinika, oddělení hematom-onkologie, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
Klinika detske hematologie a onkologie, V Uvalu 84, 150 06, Prague 5

Denmark

3 sites · Ongoing, recruiting
Odense University Hospital
Department of Pediatric Hematology and Oncology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Paediatrics and Adolescent Medicine, Hematology/Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus University
Department of Paediatrics and Adolescent Medicine, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N

Finland

5 sites · Ongoing, recruiting
HUS
Division of Hematology-Oncology and Stem Cell Transplantation, Stenbackinkatu 11, 00290, Helsinki
Oulu University Hospital
Department of pediatrics, Kajaanintie 50, 90220, Oulu
University Of Turku
Pediatric and Adolescent Medicine, P. O. Box 52, 20521, Turku
Kuopio University Hospital
Department of paediatrics, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
TAYS Sydaenkeskus Oy
Pediatrics, Dept of Hematology and Oncology, P. O. Box 2000, 33521, Tampere

France

20 sites · Ongoing, recruiting
Centre Hospitalier Universitaire De Rennes
Hématologie pédiatrique, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Assistance Publique Hopitaux De Marseille
Hématologie, oncologie et immunologie pédiatrique, 264 Rue Saint Pierre, 13005, Marseille
Besancon University Hospital Center
Hématologie et oncologie pédiatrique, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Poitiers
Pediatric Hematology-Oncology unit, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire Reims
Hématologie et oncologie pédiatrique, 45 Rue Cognacq Jay, 51100, Reims
CHU De Rouen
Hématologie et oncologie pédiatrique, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Nantes
Hématologie et oncologie pédiatrique, 7 Quai Moncousu, 44000, Nantes
Assistance Publique Hopitaux De Paris
Hématologie et immunologie, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire Amiens Picardie
Hématologie, oncologie et immunologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHRU De Nancy
Hématologie et oncologie pédiatrique, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Nice
Hématologie et oncologie pédiatrique, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Saint Etienne
Hématologie et oncologie pédiatrique, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Centre Hospitalier Universitaire De Lille
Hématologie pédiatrique, Avenue Eugene Avinee, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Hématologie et oncologie pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Hématologie, oncologie et immunologie pédiatrique, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Toulouse
Hématologie, oncologie et immunologie pédiatrique, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Hématologie et oncologie pédiatrique, Place Amelie Raba Leon, 33000, Bordeaux
Les Hopitaux Universitaires De Strasbourg
Hématologie et oncologie pédiatrique, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Hospices Civils De Lyon
Hématologie pédiatrique, 1 Place Professeur Joseph Renaut, 69008, Lyon
Centre Hospitalier Universitaire De Montpellier
Hématologie et oncologie pédiatrique, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier

Germany

25 sites · Ongoing, recruiting
Gesundheit Nord gGmbH Klinikverbund Bremen
Paediatric Oncology, St.-Juergen-Strasse 1, Hulsberg, Bremen
Universitaetsklinikum Muenster AöR
Paediatric Haematology and Oncology, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Tuebingen AöR
Paediatrics 1 (general paediatrics, haematology and oncology), Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaetsklinikum Heidelberg AöR
Clinic Pediatrics III, Im Neuenheimer Feld 430, Neuenheim, Heidelberg
Universitaetsklinikum Duesseldorf AöR
Paediatric Oncology, Haematology and Clinical Immunology, Moorenstrasse 5, Bilk, Duesseldorf
University Medical Center Hamburg-Eppendorf
Paediatric Haematology and Oncology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Halle (Saale) AöR
Clinic and Polyclinic for Paediatrics I, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Charite Universitaetsmedizin Berlin KöR
Paediatric clinic with a focus on Oncology and Haematology, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Paediatric Haematology and Oncology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Johannes Gutenberg University Mainz
Clinic and Polyclinic for Paediatrics I, Langenbeckstrasse 1, 55101, Mainz
Universitaetsklinikum Bonn AöR
Paediatric Haematology/Oncology, Venusberg-Campus 1, Venusberg, Bonn
Medical Center - University Of Freiburg
Paediatric Haematology and Oncology, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Pediatrics 5 (hematology, oncology, immunology), Kriegsbergstrasse 62, Mitte, Stuttgart
Justus-Liebig-Universitaet Giessen
Paediatric Haematology and Oncology, Feulgenstrasse 10-12, 35392, Giessen
Universitaetsklinikum Schleswig-Holstein AöR
Clinic for Paediatric and Adolescent Medicine I, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Aachen AöR
Pediatrics and Adolescent Medicine, Pauwelsstrasse 30, 52074, Aachen
HELIOS Klinikum Krefeld GmbH
Pediatric Oncology Center, Lutherplatz 40, Diessem/lehmheide, Krefeld
Klinikum Dortmund gGmbH
Westphalian Children's Center, Beurhausstrasse 40, Mitte, Dortmund
Medizinische Hochschule Hannover
Paediatric Haematology and Oncology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Augsburg
Clinic for Paediatric and Adolescent Medicine, Stenglinstrasse 2, Kriegshaber, Augsburg
University Hospital Cologne AöR
Paediatric Oncology and Haematology, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Ulm AöR
Paediatric Haematology and Oncology, Eythstrasse 24, Mitte, Ulm
Klinikum rechts der Isar der TU Muenchen AöR
Department of clinical Medicine, children's hospital, Koelner Platz 1, Schwabing-West, Munich
Universitaetsklinikum Erlangen AöR
Paediatric Oncology and Haematology, Loschgestrasse 15, Innenstadt, Erlangen
Universitaetsklinikum Frankfurt AöR
Paediatric Haematology and Oncology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Greece

7 sites · Authorised, recruiting
University General Hospital Of Heraklion
Hematology-Oncology Children’s Clinic, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Of Thessaloniki Ahepa
Pediatric and Adolescent Hematology-Oncology Unit, 2nd Pediatric Department of Aristotle University, 1st St Kiriakidis Str, 546 36, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
Pediatric-Oncology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Nosokomeio Paidon I Agia Sofia
Department of Pediatric Hematology and Oncology (TAO), Thivon, Papadiamantopoulou, Athens
Mitera S.A.
Children's - Adolescent's Oncology Clinic, Erythrou Stavrou Str 6, 151 23, Marousi
Nosokomeio Paidon I Agia Sofia
Universtiy unit of Pediatric Oncology - Hematology (POHem), Thivon, Papadiamantopoulou, Athens
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Oncology Department Aglaia Kyriakou (OTAK), Thivon And Leivadias, Ampelokipoi, Athens

Hungary

2 sites · Ongoing, recruiting
Semmelweis University
Department of pediatrics, Tuzolto Utca 7-9, 1094, Budapest
University Of Pecs
Department of pediatrics, Jozsef Attila Utca 7, 7623, Pecs

Ireland

1 site · Ongoing, recruiting
Children's Health Ireland
Paediatric Haematology, Cooley Road, Crumlin, Dublin

Italy

21 sites · Ongoing, recruiting
Ospedale Pediatrico Bambino Gesu'
Dipartimento di Onco-Ematologia, Terapia Cellulare, Terapie Geniche e Trapianto Emopoietico, Piazza Sant'onofrio 4, 00165, Rome
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncoematologia pediatrica e TMO, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
U.O.C. Ematologia ed Oncologia Pediatrica con TMO, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD Oncoematologia Pediatrica, Via Pietro Albertoni 15, 40138, Bologna
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Dipartimento di Oncologia, Presidio Ospedaliero Santobono, Via Mario Fiore 6, Naples
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Servizio di Oncologia Pediatrica - DAI Materno Infantile, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Dipartimento di Pediatria, Piazza Oms 1, 24127, Bergamo
University Of Verona Medical School
U.O.C Oncoematologia Pediatrica, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliero Universitaria Parma
Unità di Pediatria e Onco-Ematologia, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero Universitaria Delle Marche
SOsD Oncoematologia Pediatrica, Via Conca 71, 60126, Ancona
Fondazione IRCCS Policlinico San Matteo
S.C. Oncoematologia Pediatrica, Viale Camillo Golgi 19, 27100, Pavia
Giannina Gaslini Institute For Scientific Hospitalization And Care
UOC Ematologia, Via Gerolamo Gaslini 5, 16147, Genoa
ARNAS Civico Di Cristina Benfratelli
U.O. Oncoematologia Pediatrica, Piazza Nicola Leotta 4, 90127, Palermo
Azienda Ospedale-Universita Padova
Maternal and Child Health Department, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera-Universitaria Di Cosenza
U.O.C. di Pediatria – Dipartimento Materno-Infantile, Via Felice Migliori 1, 87100, Cosenza
University Hospital Consorziale Policlinico
Pediatria ad indirizzo oncoematologico, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
S.C. Oncologia Pediatrica, Piazza Polonia 94, 10126, Turin
Azienda Ospedaliera Universitaria Meyer IRCCS
Pediatric Oncology and Hematology Department, Viale Gaetano Pieraccini 24, 50139, Florence
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Dipartimento Pediatrico S.C. Oncoematologia Pediatrica, Via Dell' Istria 65/1, 34137, Trieste
ARNAS G. Brotzu
Dipartimento Materno-Infantile, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Fondazione IRCCS San Gerardo Dei Tintori
Dipartimento di Pediatria, Via Giovanni Battista Pergolesi 33, 20900, Monza

Lithuania

1 site · Temporarily halted
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Center For Children Oncology and Hematology, Santariskiu G 2, Vilniaus M. Sav., Vilnius

Netherlands

1 site · Ongoing, recruiting
Princess Maxima Center For Pediatric Oncology
Hematology, Heidelberglaan 25, 3584 CS, Utrecht

Norway

4 sites · Authorised, recruiting
Oslo University Hospital HF
Deparment of Pediatric Oncology and Hematology, P. O. Box 4950, 0424, Oslo
St. Olavs Hospital HF
Dep. Pediatric hematology and oncology, Prinsesse Kristinas G. 3, 7030, Trondheim
Helse Bergen HF
Children and Youth Clinica, Pediatric oncology/hematology unit, P. O. Box 1400, 5021, Bergen
University Hospital Of North Norway HF
Pediatric dept. Oncology and hematology unit, P. O. Box 100, 9038, Tromsoe

Poland

16 sites · Ended
Uniwersytecki Szpital Dzieciecy W Krakowie
Oddzial Onkologii I Hematologii Dzieciecej.Dept of pediatric oncology and hematology, Ul. Wielicka 265, 30-663, Cracow
Uniwersyteckie Centrum Kliniczne
Klinika Pediatrii, Hematologii I Onkologii w Gdansku, Ul. Debinki 7, 80-211, Gdansk
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Klinika Pediatrii Hematologii I Onkologii, Ul. Marii Curie Sklodowskiej 9, 85-094, Bydgoszcz
Uniwersytecki Szpital Dzieciecy W Lublinie
Klinika Onkologii, Hematologii I Transplantologii Dzieciecej, Ul. Prof. Antoniego Gebali Nr 6, 20-093, Lublin
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej
Klinika Onkologii i Hematologii Dzieciecej, Ul. Jerzego Waszyngtona 17, 15-269, Bialystok
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Oddzial Hematologii I Onkologii Dzieciecej, Ul. Strzelcow Bytomskich 11, 41-500, Chorzow
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Dept of Pediatric Oncology, Hematology and Chemotherapy, Ul. Medykow 16, 40-752, Katowice
Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu
Szpital Dzieciecej im Karola Jonschera, Ul. Szpitalna 27/33, 60-572, Poznan
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Klinika Onkohematologii Dzieciecej, Ul. Lwowska 60, 35-301, Rzeszow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Oddzial Hemato-Onkologii Dzieciecej, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Klinika Transplantacji Szpiku, Onkologii I Hematologii Dzieciecej, Ul. Borowska 213, 50-556, Wroclaw
Wojewodzki Szpital Zespolony W Kielcach SPZOZ
Klinika Pediatrii, Oddzial Onkologii I Hematologii Dzieciecej, Ul. Grunwaldzka 45, 25-736, Kielce
Wojewodzki Szpital Specjalistyczny W Olsztynie
Oddzial Kliniczny Onkologii I Hematologii, Ul. Zolnierska 18, 10-561, Olsztyn
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Oddział Kliniczny Pediatrii, Hematologii i Onkologii, Ul. Zwirki I Wigury 63a, 02-091, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Katedra i Klinika Pediatrii, Hematologii i Onkologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Klinika PediatriiOnkologii i Hematologii/ Oddzial Onkologii I Hematologii dia Dzieci Mlodszuch, Ul. Pomorska Nr 251, 92-213, Lodz

Portugal

3 sites · Temporarily halted
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Pediatria, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Serviço de Pediatria, Rua Professor Lima Basto, 1099-023, Lisbon
Centro Hospitalar E Universitario De Coimbra E.P.E.
Serviço de Oncologia Pediátrica, Avenida Afonso Romao, 3000-602, Coimbra

Slovakia

1 site · Temporarily halted
Narodny Ustav Detskych Chorob
Department of Pediatric Hematology and Oncology, Limbova 1, 833 40, Bratislava

Spain

4 sites · Ongoing, recruiting
Vall D'hebron Institut De Recerca
Pediartic Oncology-Hematology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Pediatric, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Pediatric Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Infantil Universitario Nino Jesus
Pediatric Hematology-Oncology, Avenida Menendez Pelayo 65, 28009, Madrid

Sweden

6 sites · Ongoing, recruiting
Norrlands University Hospital
Avdelningen för pediatrisk hematologi och onkologi, Barn 3, Umea Universitet, 901 85, Umea
Uppsala University Hospital
95A, Avdelning för blod- och tumörsjukdomar hos barn, Akademiska Sjukhuset, 751 85, Uppsala
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Barncancercentrum, Behandlingsvagen 7, Harlanda, Gothenburg
Region Skane Skanes Universitetssjukhus
Barncancercentrum, Entregatan 7, Lunds Allhelgonafors, Lund
Karolinska University Hospital
Barnonkologen, “-“, 171 76, Stockholm
Linkoping University Hospital Region Ostergotland
Barnonkologen B153 BOND, Universitetssjukhuset I Linkoping, 581 85, Linkoping

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2024-03-20 2025-06-26 2025-07-15
Belgium 2024-05-02 2025-01-27 2025-07-15
Czechia 2023-09-27 2023-09-27
Denmark 2023-08-28 2024-01-17
Finland 2023-08-28 2024-03-28
France 2025-03-20 2025-04-04
Germany 2024-07-30 2024-11-21
Greece 2025-02-06
Hungary 2023-10-02 2024-02-15
Ireland 2024-09-10 2024-12-24
Italy 2024-11-14 2024-12-04
Lithuania 2024-10-31
Netherlands 2022-12-15 2023-01-13
Norway 2023-10-09
Portugal 2025-01-08 2025-01-15 2025-07-15
Slovakia 2024-12-06 2024-12-06 2025-07-15
Spain 2024-08-26 2024-09-23
Sweden 2024-03-27 2024-06-11

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 17 · Art. 38 CTR

Temporary halt TH-90579

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Slovakia
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90568

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Finland
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90578

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Germany
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90567

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Denmark
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90577

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Lithuania
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90566

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Czechia
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90576

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
France
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90565

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Austria
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90575

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Ireland
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90564

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Netherlands
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90574

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Belgium
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90573

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Italy
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90572

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Portugal
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90571

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Norway
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90581

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Greece
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90570

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Sweden
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Temporary halt TH-90580

Halt date
2025-07-15
Planned restart
2025-10-06
Member states concerned
Spain
Publication date
2025-07-15
Reason
Safety related (clinical or pre-clinical results), Sponsor decision
Explanation
See US-90558
Follow-up measures
See US-90558
Benefit-risk balance changed
Yes
Treatment stopped
No

Urgent safety measures 2 · Art. 54 CTR

Urgent safety measure US-127734

Event date
2026-04-07
Submission date
2026-04-07
In response to
OTHER
Member states affected
Netherlands, Austria, Czechia, Denmark, Finland, Hungary, Sweden, Norway, Poland, Portugal, Italy, Belgium, Ireland, France, Lithuania, Germany, Slovakia, Spain, Greece
Event description
Please find enclosed the Quarterly Safety Report #1 for the application concerning the Interfant-21 trial for your review.
This Safety Report has been prepared in response to the request outlined in SM-14 under the following condition:
1. Please submit safety reports (clinical data, how many patients receive treatment in individual centers in individual countries, etc.) every three months during the first year and then every six months thereafter from the time the enrollment is restarted. This can be submitted as a Non- Substantial Modification. If necessary, an Ad Hoc Assessment will be started by the Member States/RMS.
Measures taken
Since it was not possible to submit the Quarterly Safety Report as a NSM, we have decided to submit the report as an USM.

Urgent safety measure US-90558

Event date
2025-07-15
Submission date
2025-07-15
In response to
OTHER
Member states affected
Netherlands, Austria, Czechia, Denmark, Finland, Hungary, Sweden, Norway, Poland, Portugal, Italy, Belgium, Ireland, France, Lithuania, Germany, Slovakia, Spain, Greece
Event description
Enrollment in the study will be suspended based on the recommendation of the DSMB due to 2 more related death (total 6) out of the current 50 enrolled patients during induction therapy (standard of care chemotherapy) since the previous USM (US-79610). The DSMB advised halting enrollment until protocol version 2.0 with revised dosing guidelines is approved by regulatory authorities and activated. The revised protocol version 2.0 is submitted by SM-14 on 24Jun2025 and currently under review. The 2 other death received the previous dosing guidelines as described in protocol version 1.4 even though the USM (US-79610) has been communicated to all Sites.
Measures taken
The national principal investigators and other parties/involved vendors have been informed by email of the temporary recruitment halt as of today. In the meantime, the Sponsor will develop a plan for formally re-training participating sites/investigators regarding dosing and for real-time dose monitoring during the induction phase, as recommended by the DSMB. This plan will be submitted for DSMB review and approval. For the patients that have been enrolled, the principal investigators have verified that the patient is receiving the correct dosing guidelines. These patients will continue the treatment plan following protocol version 2.0/USM (US-79610).

Corrective measures 2 · Art. 77 CTR

Corrective measure CM-HU-0001

Member state
Hungary
Publication date
2026-03-10
Type
5
Reason
3
Reverted date
2026-03-10
Immediate action required
Yes
Notes
Reverted (2026-03-10)
Justification
The Ethics Committee ETT-KFEB requests the immediate suspension of the CT in Hungary.

Corrective measure CM-HU-0002

Member state
Hungary
Publication date
2026-03-10
Type
3
Reason
3
Immediate action required
No
Justification
This is a technical corrective measure linked to CM-HU-0001, aimed to raise a 2ndRFI. Hungarian Central Ethics Committee didn't accept the responses, they consider it incomplete. They raised the following second RFIs: 1.The deaths should be treated as a SUSAR and analysed in detail. These documents (eg. individual case reports) should be submitted. The reason for treating this as a SUSAR and not an SAE is, that in the Interfant-21 trial, chemotherapy was not administered at the approved dose, it is not considered as standard care. 2. A revised risk/benefit analysis should be submitted, which focuses on the entire study, and not only to the test IMP. Risk analysis should be complex, and should include all relevant experience and data originated from the study. 3. Protocol modification in USM, should be submitted as a Substatial Modification. 4. ICF/PIS should be modified.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 125 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol [2022-502503-30-00]_Redacted 2-0
Protocol (for publication) D1. Protocol [2022-502503-30-00]_Redacted 2.1
Protocol (for publication) D1. Protocol GR [2022-502503-30-00]_REDACTED 2.1
Protocol (for publication) D1. Protocol Substudy Goldilocks [2022-502503-30-00]_Redacted 1.4
Protocol (for publication) D1. Protocol Substudy Goldilocks GR [2022-502503-30-00]_REDACTED 1.4
Protocol (for publication) D1. Protocol Substudy Immunomonitoring [2022-502503-30-00]_Redacted 1.3
Protocol (for publication) D1. Protocol Substudy Immunomonitoring GR [2022-502503-30-00]_REDACTED 1-3
Protocol (for publication) D1. Protocol Substudy NeurocognitiveDevelopment [2022-502503-30-00]_Redacted 1-4
Protocol (for publication) D1. Protocol Substudy NeurocognitiveDevelopment GR [2022-502503-30-00]_REDACTED 1.4
Protocol (for publication) D1. Protocol Substudy Pharmacokinetics [2022-502503-30-00]_Redacted 1.3
Protocol (for publication) D4. Patient facing documents [questionnaire ABAS3_adaptive_0-4years_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire ABAS3_adaptive_5years plus_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire ABAS3-Parent-form-0-5years]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire ABAS3-parent-form-5-21yrs]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire BRIEF_ENG-Parent]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire BRIEF2_EF_5 year plus_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire BRIEF2P_ENG-Parent-teacher]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire BRIEFP_EF_2-5 year_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire English proxy MEES paper version child]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire Greek SDQ_parent-2-4single]_REDACTED 1
Protocol (for publication) D4. Patient facing documents [questionnaire Greek SDQ_parent-4-17single]_REDACTED 1
Protocol (for publication) D4. Patient facing documents [questionnaire MEES_EducationParentNL]_Redacted 1-1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL FIM NL]_Redacted 2-0
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL_Fatigue-5-7year_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL_Fatigue2-4year_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL_generic_5-7year_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL_generic2-4year_parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL_Infant-0-24MonthsParentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL-2-0-FIM-All_AU2-0_eng-USori]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL-3-0-Fatigue-All_AU3-0_eng-USori_2-4_5-7]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL-4-0-Core-All_AU4-0_eng-USori_2-4_5-7]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire PedsQL-Infant-All_eng-USori]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire SDQ_behavior_2-3 jaarParentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire SDQ_behavior_4 year plus parentNL]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire SDQ_English-UK_parent-4-17single]_Redacted 1
Protocol (for publication) D4. Patient facing documents [questionnaire SDQ_English-UK_parent2-4single]_Redacted 1
Recruitment arrangements (for publication) K1_Enrollment plan_CTR_Norway 1
Recruitment arrangements (for publication) K1_IF21_Clarification of patients recruitment process_Finland 2
Recruitment arrangements (for publication) K1_IF21_Modalidade de Recrutamento 1
Recruitment arrangements (for publication) K1_IF21_Recruitment arrangements explanatory note_Hungary 1
Recruitment arrangements (for publication) K1_IF21_Recruitment Arrangements_Austria_[2022-502503-30-00] 1
Recruitment arrangements (for publication) K1_IF21_Recruitment_and_ICprocedure_Finland 2
Recruitment arrangements (for publication) K1_IF21_RecruitmentAndICProcedure_Czechia 1
Recruitment arrangements (for publication) K1_IF21_RecruitmentArrangement_Sweden 1
Recruitment arrangements (for publication) K1_IF21_RecruitmentArrangements_Denmark_2022-502503-30-00 1
Recruitment arrangements (for publication) K1_IF21_RecruitmentArrangements_POLAND_REDACTED 2
Recruitment arrangements (for publication) K1_IF21_SiteList_POLAND_REDACTED 1
Recruitment arrangements (for publication) K1_IF21_SiteList_Sweden 1
Recruitment arrangements (for publication) K1_IF21_Study sites list_Finland_REDACTED 2.0
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure_Norway 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements FR_2022-502503-30-00 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_REDACTED 1
Recruitment arrangements (for publication) K1_Recruitment of subjects 1
Recruitment arrangements (for publication) K1_recruitmentprocedure_en 1
Recruitment arrangements (for publication) K1_Template_ Recruitment_ Arrangements_ Ireland 1
Recruitment arrangements (for publication) K1. Recruitment Arrangements [Princess Maxima Center] 1
Recruitment arrangements (for publication) K1. Template Recruitment arrangements 1.0
Subject information and informed consent form (for publication) L1_ ICF_ Parents_or_Legal Guardian_ Ireland_Redacted 2.0
Subject information and informed consent form (for publication) L1_Annex A to SIS AND ICF [Master Site_privacy notice and consent privacy minors] 2.1
Subject information and informed consent form (for publication) L1_ICF_Biobanking Data Processing_REDACTED 1
Subject information and informed consent form (for publication) L1_ICF_Biobanking Participation_REDACTED 1
Subject information and informed consent form (for publication) L1_IF21_Consent Form_Sweden 2.0
Subject information and informed consent form (for publication) L1_IF21_DescriptionObtainingICF_POLAND_REDACTED 1
Subject information and informed consent form (for publication) L1_IF21_ICF_ProcessingPersonalData_Czechia 1
Subject information and informed consent form (for publication) L1_IF21_MasterICF Behandlung_Eltern_Austria_[2022-502503-30-00]_REDACTED 4
Subject information and informed consent form (for publication) L1_IF21_MasterICF Vorregistrierung_Eltern_Austria_[2022-502503-30-00] 1
Subject information and informed consent form (for publication) L1_IF21_PIF_Sweden_REDACTED 4
Subject information and informed consent form (for publication) L1_IF21_PIF-ICF_Portugal 2.0
Subject information and informed consent form (for publication) L1_IF21_PIFICF_Parents_Czechia 2.1
Subject information and informed consent form (for publication) L1_IF21_PIFICF_Podstudie_farmakokinetika__Czechia 1.1
Subject information and informed consent form (for publication) L1_IF21_PIFICF_Podstudie_goldilocks__Czechia 2.0
Subject information and informed consent form (for publication) L1_IF21_PIFICF_Podstudie_imunomonitoringu_Czechia 1.1
Subject information and informed consent form (for publication) L1_IF21_PIFICF_Podstudie_neurokognitivniho vyvoje__Czechia 1.1
Subject information and informed consent form (for publication) L1_IF21_SIS and ICF_Denmark_2022-502503-30-00 1.4
Subject information and informed consent form (for publication) L1_IF21_SIS and ICF_Hungary_REDACTED 2.1
Subject information and informed consent form (for publication) L1_IF21_SIS and ICF_Substudies_Denmark_2022-502503-30-00 1.4
Subject information and informed consent form (for publication) L1_IF21_SISandICF_Parents_Norway_REDACTED 2.0
Subject information and informed consent form (for publication) L1_IF21_SISandICF_Parents_Norway_TC_REDACTED 2.0
Subject information and informed consent form (for publication) L1_IF21_SISICF_Parents_Finland_Goldilocks substudy_REDACTED 2
Subject information and informed consent form (for publication) L1_IF21_SISICF_Parents_Finland_Neurocognitive substudy_REDACTED 1
Subject information and informed consent form (for publication) L1_IF21_SISICF_Parents_Finland_REDACTED 4
Subject information and informed consent form (for publication) L1_IF21_SISICF_POLAND_REDACTED 3.00
Subject information and informed consent form (for publication) L1_IF21_Zentrumsspezifische Kontaktdaten_[2022-502503-30-00]_REDACTED 3.0
Subject information and informed consent form (for publication) L1_Interfant-21_ICF_GR_Redacted 2.0
Subject information and informed consent form (for publication) L1_Letter to the treating physician 1
Subject information and informed consent form (for publication) L1_Powerof Attorney_Denmark_2022-502503-30-00 1
Subject information and informed consent form (for publication) L1_SIS and ICF autorite parentale FR_2022-502503-30-00 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF infants under one year_public 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF sub-study central nervous system FR_2022-502503-30-00 2
Subject information and informed consent form (for publication) L1_SIS and ICF sub-study immunomonitoring FR_2022-502503-30-00 1-1
Subject information and informed consent form (for publication) L1_SIS and ICF sub-study neurocognitive FR_2022-502503-30-00 2
Subject information and informed consent form (for publication) L1_SIS and ICF sub-study pharmacocinetiks FR_2022-502503-30-00 1-1
Subject information and informed consent form (for publication) L1_SIS and ICF_DU_Parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ENG_Parents NA
Subject information and informed consent form (for publication) L1_SIS and ICF_ENG_Parents_BE 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_Parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_LT_Parents_REDACTED 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents NA
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents_redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents_rv NA
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents_SK 2.0
Subject information and informed consent form (for publication) L1_SIS_ Parents_ or_Legal Guardian_ Ireland_Redacted 2.0
Subject information and informed consent form (for publication) L1. ICF BIOBANKING_POLAND 1
Subject information and informed consent form (for publication) L1. SIS AND ICF [minors] 2.2
Subject information and informed consent form (for publication) L1. SIS and ICF [Parents-Guardians] Redacted 2.0
Subject information and informed consent form (for publication) L1. SIS AND ICF [privacy notice ICF privacy minors]_REDACTED 1.0
Subject information and informed consent form (for publication) L2_IF21_PatientCard_Czechia 1
Subject information and informed consent form (for publication) L2_IF21_PatientIDcard_11Feb2023 1
Subject information and informed consent form (for publication) L2_IF21_personal data protection_POLAND 2
Summary of Product Characteristics (SmPC) (for publication) G2. SmPC [Blincyto] NA
Synopsis of the protocol (for publication) D1_IF21_Protocol synopsis_Czechia_[2022-502503-30-00] 2.0
Synopsis of the protocol (for publication) D1_IF21_Protocol synopsis_Denmark_2022-502503-30-00 1
Synopsis of the protocol (for publication) D1_IF21_Protocol synopsis_France_[2022-502503-30-00] 1-0
Synopsis of the protocol (for publication) D1_IF21_Protocol synopsis_Portugal_[2022-502503-30-00] 1
Synopsis of the protocol (for publication) D1_IF21_Protocol synopsis_Slovakia_[2022-502503-30-00] 1
Synopsis of the protocol (for publication) D1_IF21_Protocol_Synopsis_Austria_[2022- 502503-30-00] 1
Synopsis of the protocol (for publication) D1_IF21_Protocol_Synopsis_English_[2022-502503-30-00] 1
Synopsis of the protocol (for publication) D1_IF21_Protocol_Synopsis_Greece_2022-502503-30-00 1
Synopsis of the protocol (for publication) D1_IF21_Protocol_Synopsis_Lithuanian_[2022-502503-30-00] 1
Synopsis of the protocol (for publication) D1_IF21_Protocol_Synopsis_Spain_[2022-502503-30-00] 1.3
Synopsis of the protocol (for publication) D1_Protocol Synopsis_Italy_[2022-502503-30-00] 1
Synopsis of the protocol (for publication) D1. Protocol synopsis_NL [2022-502503-30-00]_Redacted 1

Application history

36 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-29 Netherlands Acceptable
2023-02-07
 2023-02-07
2 SUBSTANTIAL MODIFICATION SM-1 2023-02-23 Netherlands Acceptable
2023-04-18
 2023-04-18
3 SUBSEQUENT ADDITION OF MSC APP-3 2023-05-01 Acceptable
2023-02-07
 2023-06-26
4 SUBSEQUENT ADDITION OF MSC APP-4 2023-05-01 2023-07-12
5 SUBSEQUENT ADDITION OF MSC APP-5 2023-05-01 2023-07-03
6 SUBSEQUENT ADDITION OF MSC APP-6 2023-05-01 2023-07-14
7 SUBSEQUENT ADDITION OF MSC APP-7 2023-05-01 Acceptable
2023-04-18
 2023-07-20
8 SUBSEQUENT ADDITION OF MSC APP-8 2023-05-02 Acceptable
2023-04-18
 2023-07-10
9 SUBSEQUENT ADDITION OF MSC APP-9 2023-05-02 Acceptable
2023-04-18
 2023-07-26
10 SUBSEQUENT ADDITION OF MSC APP-10 2023-05-02 2023-07-14
11 SUBSEQUENT ADDITION OF MSC APP-11 2023-05-16 2023-08-01
12 NON SUBSTANTIAL MODIFICATION NSM-1 2023-08-18 2023-08-18
13 SUBSTANTIAL MODIFICATION SM-2 2023-09-04 Acceptable 2023-09-05
14 SUBSTANTIAL MODIFICATION SM-3 2023-10-19 Acceptable 2024-02-09
15 SUBSEQUENT ADDITION OF MSC APP-15 2023-11-28 2024-03-08
16 SUBSEQUENT ADDITION OF MSC APP-16 2023-11-28 Acceptable
2023-02-07
 2024-03-05
17 SUBSEQUENT ADDITION OF MSC APP-17 2023-12-06 2024-03-15
18 SUBSEQUENT ADDITION OF MSC APP-18 2024-01-10 2024-03-22
19 SUBSEQUENT ADDITION OF MSC APP-19 2024-01-17 Acceptable
2023-02-07
 2024-03-28
20 SUBSEQUENT ADDITION OF MSC APP-20 2024-01-31 Acceptable
2023-02-07
 2024-04-25
21 SUBSTANTIAL MODIFICATION SM-4 2024-02-01 Acceptable 2024-03-12
22 SUBSEQUENT ADDITION OF MSC APP-22 2024-02-05 2024-04-30
23 SUBSTANTIAL MODIFICATION SM-5 2024-02-22 Acceptable 2024-03-08
24 SUBSTANTIAL MODIFICATION SM-6 2024-02-29 Acceptable 2024-04-15
25 SUBSTANTIAL MODIFICATION SM-7 2024-03-05 Acceptable 2024-04-03
26 SUBSEQUENT ADDITION OF MSC APP-26 2024-04-11 Acceptable
2023-02-07
 2024-06-07
27 SUBSEQUENT ADDITION OF MSC APP-27 2024-04-11 Acceptable
2023-02-07
 2024-07-04
28 SUBSTANTIAL MODIFICATION SM-8 2024-04-25 Acceptable 2024-06-12
29 SUBSTANTIAL MODIFICATION SM-11 2024-11-28 Netherlands Acceptable
2025-03-24
 2025-03-24
30 SUBSTANTIAL MODIFICATION SM-12 2025-04-03 Acceptable 2025-04-25
31 SUBSTANTIAL MODIFICATION SM-13 2025-04-03 Acceptable 2025-05-12
32 SUBSTANTIAL MODIFICATION SM-14 2025-06-24 Netherlands Acceptable with conditions
2025-09-29
 2025-09-30
33 SUBSTANTIAL MODIFICATION SM-16 2025-11-13 Netherlands Acceptable
2026-01-27
 2026-01-27
34 SUBSTANTIAL MODIFICATION SM-15 2026-04-03 Acceptable 2026-04-23
35 SUBSTANTIAL MODIFICATION SM-16 2026-04-14 Acceptable 2026-05-11
36 SUBSTANTIAL MODIFICATION SM-17 2026-04-28 Acceptable 2026-05-25

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