Lymphoblastic… · Phase III (2023-508101-24-00)

Start 1 Aug 2019 · Status Ongoing, recruiting · 14 EU/EEA countries · 172 sites · Protocol UKM17_0023

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 559

Countries 14

Sites 172

Lymphoblastic lymphoma

Key facts

Sponsor: Universitaetsklinikum Muenster AöR
Participant type: Pediatric, Patients
Age range: 0-17 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 1 Aug 2019 → ongoing
Decision date (initial): 2024-04-15
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2023-508101-24-00
EudraCT number: 2017-001691-39
ClinicalTrials.gov: NCT04043494

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety, Therapy

The primary objective of the first randomized question (R1) open for all LBL patients (pts) of the core study cohort, is to evaluate whether the
cumulative incidence of relapses in the central nervous system can be decreased by substituting prednisone (60 mg/m²/d for 21 days plus a 9
day tapering) (standard arm, SA) by dexamethasone (10 mg/m²/d for 14 days without tapering) (experimental arm, EA) in induction therapy.
The primary objective of the second randomized question (R2) open for high-risk pts of the core study cohort, is to test whether the probability
of pEFS can be improved by an intensified treatment arm (EA) compared to the standard treatment arm (SA). In the EA pts receive 2 additional
doses of PEG asparaginase during protocol Ib* and an intensified protocol M consisting of one course for high-risk (HR) ALL (HR-1'),
followed by one standard high-dose methotrexate (MTX) course, followed by another intense course for HR ALL (HR-2') and a second
standard high-dose MTX course.

Secondary objectives 7

The pEFS and cumulative incidence of relapse/CNS-relapse as compared to study EURO-LB 02
Overall survival (pOS) defined as time from diagnosis to death of any cause or to date of last contact for patients alive as compared to study EURO-LB 02
Treatment related mortality in the randomized arms and compared to study EURO-LB 02
Adverse event and severe adverse event profile in specific protocol elements or randomized arms and during follow-up and compared to study EURO-LB 02
Feasibility and results of risk group stratification
Feasibility of minimal residual disease evaluation in children and adolescents with LBL
Identification of prognostic molecular markers for T-LBL which can be added to the risk group stratification system in a subsequent trial (PTEN mutations and deletions, PIK3CA, PIK3R1, KRAS, NRAS, chromosome 6q alterations, status of TRG locus and further molecular markers identified in the targeted panel of molecular markers for T-LBL)

Conditions and MedDRA coding

Lymphoblastic lymphoma

Version	Level	Code	Term	System organ class
21.0	LLT	10065923	Lymphoblastic lymphoma	10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Newly diagnosed lymphoblastic lymphoma
Age <18 years at diagnosis
Patient enrolled in a participating center
Written informed consent of patient (>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
Willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular)pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

Exclusion criteria 8

Lymphoblastic lymphoma as secondary malignancy
Non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment including among others : - prior organ transplant - severe immunodeficiency - demyelinating Charcot-Marie Tooth syndrome - serious acute or chronic infections, such as HIV, VZV and tuberculosis - urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (e.g. creatinine clearance less than 20 ml/min) - severe hepatic impairment (bilirubin >3 times ULN, transaminases >10 times ULN) - myocardial insufficiency, severe arrhythmias - ulcers of the oral cavity and known active gastrointestinal ulcer disease - known hypersensitivity to any IMP and to any excipient
Steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
Vaccination with live vaccines within 2 weeks before start of protocol Treatment
Treatment started according to another protocol or pre-treatment with cytostatic drugs (except INITIAL EMERGENCIES)
Participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
Evidence of pregnancy or lactation period
Sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 12 months after end of cytostatic therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

Primary endpoints of randomization 1: For the randomized question 1 the cumulative incidence of relapse with involvement of the CNS (CNS-relapse, pCICR) is the primary endpoint.
Primary endpoints of randomization 2: For the randomized question 2 the estimated probability of event-free survival (pEFS) is the primary endpoint.

Investigational products

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

Test 14

Ifosfamide

SCP11431448 · ATC

Active substance: Ifosfamide
Route of administration: INTRAVENOUS USE
Max daily dose: 1600 mg/m2 milligram(s)/sq. meter
Max total dose: 4000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: L01AA06 — IFOSFAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate Sodium

SCP10339494 · ATC

Active substance: Methotrexate Sodium
Substance synonyms: SODIUM METHOTREXATE, MTX SODIUM
Route of administration: INTRAVENOUS USE
Max daily dose: 5 gm/m2 gram(s)/square meter
Max total dose: 20 gm/m2 gram(s)/square meter
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: L01BA01 — METHOTREXATE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisone

SCP131338 · ATC

Active substance: Prednisone
Route of administration: INTRAVENOUS USE AND ORAL USE
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 1837.5 mg/m2 milligram(s)/sq. meter
Max treatment duration: 37 Day(s)
Authorisation status: Authorised
ATC code: H02AB07 — PREDNISONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vincristine Sulfate

SCP1137788 · ATC

Active substance: Vincristine Sulfate
Route of administration: INTRAVENOUS USE
Max daily dose: 2 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 10 Day(s)
Authorisation status: Authorised
ATC code: L01CA02 — VINCRISTINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pegaspargase

SCP30502979 · ATC

Active substance: Pegaspargase
Substance synonyms: PEG-Asparaginase, PEG-L-Asparaginase
Route of administration: INTRAVENOUS USE
Max daily dose: 3750 IU international unit(s)
Max total dose: 18750 IU international unit(s)
Max treatment duration: 5 Day(s)
Authorisation status: Authorised
ATC code: L01XX24 — PEGASPARGASE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Doxorubicin Hydrochloride

SCP138158 · ATC

Active substance: Doxorubicin Hydrochloride
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/sq. meter
Max total dose: 120 mg/m2 milligram(s)/sq. meter
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: L01DB01 — DOXORUBICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP15642072 · ATC

Route of administration: ORAL USE
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 840 mg/m2 milligram(s)/sq. meter
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: L01BB03 — TIOGUANINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daunorubicin

SCP11397391 · ATC

Active substance: Daunorubicin
Substance synonyms: DAUNOMYCIN, RUBIDOMYCIN
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/sq. meter
Max total dose: 150 mg/m2 milligram(s)/sq. meter
Max treatment duration: 5 Day(s)
Authorisation status: Authorised
ATC code: L01DB02 — DAUNORUBICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cyclophosphamide

SCP130444 · ATC

Active substance: Cyclophosphamide
Route of administration: INTRAVENOUS USE
Max daily dose: 1000 mg/m2 milligram(s)/sq. meter
Max total dose: 4000 mg/m2 milligram(s)/sq. meter
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vindesine Sulfate

SCP14962750 · ATC

Active substance: Vindesine Sulfate
Substance synonyms: VINDESINE SULPHATE
Route of administration: INTRAVENOUS USE
Max daily dose: 5 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: L01CA03 — VINDESINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cytarabine

SCP142361 · ATC

Active substance: Cytarabine
Substance synonyms: ARA-C, CYTOSINE ARABINOSIDE
Route of administration: INTRAVENOUS USE
Max daily dose: 4000 mg/m2 milligram(s)/sq. meter
Max total dose: 5800 mg/m2 milligram(s)/sq. meter
Max treatment duration: 25 Day(s)
Authorisation status: Authorised
ATC code: L01BC01 — CYTARABINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone Acetate

SCP10332310 · ATC

Active substance: Dexamethasone Acetate
Route of administration: INTRAVENOUS USE AND ORAL USE
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 576.25 mg/m2 milligram(s)/sq. meter
Max treatment duration: 54 Week(s)
Authorisation status: Authorised
ATC code: H02AB02 — DEXAMETHASONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SCP13827298 · ATC

Active substance: Mercaptopurine
Substance synonyms: MERCAPTOPURINE ANHYDROUS, 3,7-DIHYDROPURINE-6-THIONE, 6-MERCAPTOPURINE, 6MP
Route of administration: ORAL USE
Max daily dose: 60 mg/m2 milligram(s)/sq. meter
Max total dose: 3080 mg/m2 milligram(s)/sq. meter
Max treatment duration: 84 Day(s)
Authorisation status: Authorised
ATC code: L01BB02 — MERCAPTOPURINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisolone

SCP1158234 · ATC

Active substance: Prednisolone
Substance synonyms: (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
Route of administration: INTRATHECAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 240 mg milligram(s)
Max treatment duration: 24 Day(s)
Authorisation status: Authorised
ATC code: H02AB06 — PREDNISOLONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Muenster AöR

Sponsor organisation: Universitaetsklinikum Muenster AöR
Address: Albert-Schweitzer-Campus 1, Sentrup Sentrup
City: Muenster
Postcode: 48149
Country: Germany

Scientific contact point

Organisation: Universitaetsklinikum Muenster AöR
Contact name: NHL-BFM study center

Public contact point

Organisation: Universitaetsklinikum Muenster AöR
Contact name: NHL-BFM study center

Third parties 13

Organisation	City, country	Duties
Odense University Hospital ORG-100007716	Odense C, Denmark	On site monitoring
Universitaet Muenster ORG-100008258	Muenster, Germany	On site monitoring, Code 12, Code 8
St. Anna Childrens Cancer Research Institute GmbH ORG-100010137	Vienna, Austria	Other
Sahlgrenska University Hospital-Vastra Gotalandsregionen ORG-100006518	Goteborg, Sweden	Other
Consorzio Per Valutazioni Biologiche E Farmacologiche ORG-100006471	Pavia, Italy	On site monitoring, Other
Universitair Ziekenhuis Gent ORG-100021542	Gent, Belgium	On site monitoring
Scientia CRO Sp. z o.o. ORG-100047739	Bydgoszcz, Poland	Other
Medizinische Hochschule Hannover ORG-100024473	Hanover, Germany	Data management, E-data capture
Turku University Hospital ORG-100030555	Turku, Finland	Laboratory analysis
Univerzita Pavla Jozefa Safarika V Kosiciach ORG-100040399	Kosice - Stare Mesto, Slovakia	On site monitoring
Julius Clinical International B.V. ORG-100028683	Zeist, Netherlands	On site monitoring
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi ORG-100018907	Lodz, Poland	Laboratory analysis
Medizinische Hochschule Hannover ORG-100024473	Hanover, Germany	Code 10

Locations

14 EU/EEA countries · 172 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruiting	26	5
Belgium	Ongoing, recruiting	32	7
Czechia	Ongoing, recruiting	10	2
Denmark	Ongoing, recruiting	11	4
Finland	Ongoing, recruiting	11	5
Germany	Ongoing, recruiting	158	53
Hungary	Authorised, recruiting	1	8
Italy	Ongoing, recruiting	84	28
Netherlands	Ongoing, recruiting	42	1
Norway	Ongoing, recruiting	16	4
Poland	Ongoing, recruiting	73	16
Slovakia	Ongoing, recruiting	1	3
Spain	Ongoing, recruiting	53	30
Sweden	Ongoing, recruiting	26	6
Rest of world Switzerland	—	15	—

Investigational sites

Austria

5 sites · Ongoing, recruiting

Medizinische Universitaet Innsbruck

Univ.-Klinik für Pädiatrie I, Anichstrasse 35, 6020, Innsbruck

Kepler Universitaetsklinikum GmbH

MC IV., Päd. Onkologie, Krankenhausstrasse 26-30, 4020, Linz

Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH

Kinderonkologie, Muellner Hauptstrasse 48, 5020, Salzburg

Medical University Of Graz

Klin. Abteilung für Pädiatrische Hämato-Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz

St. Anna Kinderspital GmbH

Hämatologische und Onkologische Abteilung, Kinderspitalgasse 6, Alsergrund, Vienna

Belgium

7 sites · Ongoing, recruiting

CHC MontLegia

Department Hématologie et oncologie pédiatrique, Boulev. De Patience Et Beajonc 2, 4000, Liege

Cliniques Universitaires Saint-Luc

Department Hématologie et oncologie pédiatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Universitair Ziekenhuis Gent

Department Paediatric Haemato-oncology, Corneel Heymanslaan 10, 9000, Gent

Antwerp University Hospital

Department Paediatric Haemato-oncology, Drie Eikenstraat 655, 2650, Edegem

UZ Leuven

Department Paediatric Haemato-oncology, Herestraat 49, 3000, Leuven

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola

Department Hématologie et oncologie pédiatrique, Jean Joseph Crocqlaan 15, 1020, Brussels

Centre Hospitalier Regional De La Citadelle

Department Hématologie et oncologie pédiatrique, Bld Du Douzieme-De-Ligne 1, 4000, Liege

Czechia

2 sites · Ongoing, recruiting

Fakultni Nemocnice V Motole

Klinika detske hematologie a onkologie, V Uvalu 84/1, Motol, Prague

University Hospital Olomouc

Department of Pediatrics, Zdravotniku 248/7, 779 00, Olomouc

Denmark

4 sites · Ongoing, recruiting

Aalborg University Hospital

Børne- og Ungeafdelingen, Reberbansgade 15, 9000, Aalborg

Rigshospitalet

Afdeling for Børn og Unge,, Blegdamsvej 9, 2100, Copenhagen Oe

Odense University Hospital

H.C. Andersen Børne- og Ungehospital, J B Winsloews Vej 4, 5000, Odense C

Aarhus Universitetshospital

Børn og Unge, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Finland

5 sites · Ongoing, recruiting

Pohjois-Savon hyvinvointialue

Lasten ja nuorten klinikka, Puijonlaaksontie 2, P. O. Box 1711, Kuopio

Tampere University Hospital

Lasten ja nuorten klinikka, Teiskontie 35, 33520, Tampere

Turku University Hospital

Paediatric onkology, Savitehtaankatu 1, 20520, Turku

Oulu University Hospital

Lasten ja nuorten tulosalue, Kajaanintie 50, 90220, Oulu

HUS-Yhtymae

HUS Uusi Lastensairaala, Haartmaninkatu 4, 00290, Helsinki

Germany

53 sites · Ongoing, recruiting

HELIOS Klinikum Krefeld GmbH

Päd. Hämatologie/Onkologie, Lutherplatz 40, Diessem/lehmheide, Krefeld

Universitaetsklinikum Augsburg

Hämatologie / Onkologie, Stenglinstrasse 2, Kriegshaber, Augsburg

Evangelisches Klinikum Bethel gGmbH

Hämatologie / Onkologie, Kantensiek 11, Gadderbaum, Bielefeld

Vestische Kinder Und Jugendklinik Datteln

Kinderonkologie und Hämatologie, Dr.-Friedrich-Steiner-Strasse 5, 45711, Datteln

Gesundheit Nord gGmbH Klinikverbund Bremen

Kinderonkologisches Zentrum-Station 3, St.-Juergen-Strasse 1, Hulsberg, Bremen

Medizinische Hochschule Hannover

Päd. Hämatologie / Onkologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover

Rostock University Medical Center

Sektion Pädiatrische Onkologie und Palliativmedizin, Schillingallee 35, Hansaviertel, Rostock

Universitaetsklinikum Regensburg AöR

Abt. Päd. Hämatologie, Onkologie, SZT, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg

Universitaetsklinikum Aachen AöR

Hämatologie / Onkologie, Pauwelsstrasse 30, 52074, Aachen

Muehlenkreiskliniken AöR

Päd. Hämatologie / Onkologie, Hans-Nolte-Strasse 1, Haeverstaedt, Minden

Klinikum der Universitaet Muenchen AöR

Pädiatrische Hämatologie / Onkologie, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich

Universitaetsklinikum Wuerzburg AöR

Päd. Onkologie und Hämatologie, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg

Goethe University Frankfurt

Pädiatrische Hämatologie und Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main

Universitaetsklinikum des Saarlandes AöR

Päd. Hämatologie und Onkologie, Kirrberger Strasse 100, 66421, Homburg

Klinikum rechts der Isar der TU Muenchen AöR

Päd. Hämatologie / Onkologie Station, Koelner Platz 1, Schwabing-West, Munich

Universitaetsklinikum Mannheim GmbH

Päd. Onkologie /Hämatologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim

HELIOS Klinikum Erfurt GmbH

Päd. Onkologie / Hämatologie, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt

Klinikum Kassel GmbH

Klinik für pädiatrische Hämatologie und Onkologie, Moenchebergstrasse 41-43, Fasanenhof, Kassel

Universitaetsklinikum Schleswig-Holstein AöR

Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck

Universitaetsklinikum Heidelberg AöR

Abt. Hämatologie / Onkologie, Im Neuenheimer Feld 430, Neuenheim, Heidelberg

Klinikum Oldenburg AöR

Abt. Hämatologie / Onkologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg

Universitaetsklinikum Duesseldorf AöR

Klinik für Päd. Hämatologie und Onkologie, Moorenstrasse 5, Bilk, Duesseldorf

Universitaet Leipzig

Abteilung für pädiatrische Onkologie, Hämatologie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig

Klinikum Dortmund gGmbH

Abt. Päd. Onkologie / Hämatologie, Beurhausstrasse 40, Mitte, Dortmund

Asklepios Klinik Sankt Augustin GmbH

Kinder-Hämatologie und Onkologie, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin

Charite Universitaetsmedizin Berlin KöR

Abt. Hämatologie / Onkologie, Augustenburger Platz 1, Wedding, Berlin

Staedtisches Klinikum Braunschweig gGmbH

Zentrum für Kinder- und Jugendmedizin, Freisestrasse 9-10, 38118, Brunswick

Klinikum Der Landeshauptstadt Stuttgart gKAöR

Pädiatrie 5 (Onkologie, Hämatologie, Immunologie), Kriegsbergstrasse 62, Mitte, Stuttgart

Cnopf'sche Kinderklinik

Pädiatrische Hämatologie /Onkologie, St.-Johannis-Mühlgasse 19, 90419, Nuernberg

Medical Center - University Of Freiburg

Päd. Hämatologie und Onkologie, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau

Universitaetsklinikum Schleswig-Holstein AöR

Päd. Onkologie / Hämatologie, Arnold-Heller-Strasse 3, Brunswik, Kiel

Staedtisches Klinikum Karlsruhe gGmbH

Kinderklinik, Moltkestrasse 90, Weststadt, Karlsruhe

Universitaetsklinikum Ulm AöR

Päd. Hämatologie und Onkologie, Eythstrasse 24, Mitte, Ulm

Universitaetsklinikum Essen AöR

Hämatologie / Onkologie, Hufelandstrasse 55, Holsterhausen, Essen

Universitaetsklinikum Erlangen AöR

Pädiatrische Onkologie / Hämatologie, Loschgestrasse 15, Innenstadt, Erlangen

Universitaetsklinikum Jena KöR

Klinik für Kinder- und Jugendmedizin, Am Klinikum 1, Lobeda, Jena

HELIOS Klinikum Berlin-Buch GmbH

Pädiatrische Hämatologie und Onkologie, Schwanebecker Chaussee 50, Buch, Berlin

HELIOS Kliniken Schwerin GmbH

Kinderonkologie/ -hämatologie, Wismarsche Strasse 393-397, 19049, Schwerin

Gemeinschaftskrankenhaus Herdecke gGmbH

Päd. Hämatologie / Onkologie, Gerhard-Kienle-Weg 4, Westende, Herdecke

Justus-Liebig-Universitaet Giessen

Zentrum für Kinderhämatologie und -onkologie, Feulgenstrasse 10-12, 35392, Giessen

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Pädiatrische Hämatologie / Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz

University Medical Center Hamburg-Eppendorf

Abt. Pädiatrische Hämatologie und Onkologie, Martinistrasse 52, Eppendorf, Hamburg

Universitaetsmedizin Goettingen

Pädiatrie I, Robert-Koch-Strasse 40, Weende, Goettingen

Technische Universitat Dresden

Klinik für Kinder- und Jugendmedizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Universitaet Muenster

Abt. Pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster

University Hospital Cologne AöR

Abt. Kinderonkologie und -hämatologie, Kerpener Strasse 62, Lindenthal, Cologne

Martin-Luther-Universitaet Halle-Wittenberg

Pädiatrische Hämatologie / Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)

Universitaetsklinikum Bonn AöR

Abt. Päd. Hämatologie / Onkologie, Venusberg-Campus 1, Venusberg, Bonn

Carl-Thiem-Klinikum Cottbus gGmbH

Station 5e, Thiemstrasse 111, Spremberger Vorstadt, Cottbus

Universitaetsmedizin Greifswald KöR

Abt. Pädiatrische Onkologie und Hämatologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald

Universitaetsklinikum Tuebingen AöR

Päd. Hämatologie / Onkologie, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen

Gemeinschaftsklinikum Mittelrhein gGmbH

Pädiatrische Hämatologie und Onkologie, Koblenzer Str 115-155, 56073, Koblenz

Universitaetsklinikum Magdeburg AöR

Päd. Hämatologie / Onkologie, Leipziger Strasse 44, 39120, Magdeburg

Hungary

8 sites · Authorised, recruiting

University Of Szeged

Szent-Gyorgyi Albert Gyermekgyogyaszati Klinika es Gyermekegeszsegugyi Kozpont, Koranyi Fasor 14-15, 6720, Szeged

Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet

Gyermekhematologiai es Ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX

Semmelweis University

Gyermekgyogyaszati Klinika, Tuzolto utcai Reszleg, Tuzolto Utca 7-9, 1094, Budapest

University Of Debrecen

Gyermekgyogyaszati Klinika, Nagyerdei Korut 98, 4032, Debrecen

Semmelweis University

Gyermekgyogyaszati Klinika, Tuzolto utcai Reszleg, Tuzolto Utca 7-9, 1094, Budapest

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Dr. Kemeny Pal Gyermek Onko-Hematologiai Osztaly, Ulloi Ut 86, Kerulet, Budapest VIII

Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz

Velkey Laszlo Gyermekegeszsegugyi Kozpont, Szentpeteri Kapu 72-76, 3526, Miskolc

University Of Pecs

Gyermekgyogyaszati Klinika, Jozsef Attila Utca 7, 7623, Pecs

Italy

28 sites · Ongoing, recruiting

Fondazione IRCCS Istituto Nazionale Dei Tumori

S.C Pediatria Oncologica, Via Giacomo Venezian 1, 20133, Milan

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

S.C. oncoematologia pediatrica e TMO, Piazzale Spedali Civili 1, 25123, Brescia

Azienda Ospedaliera Universitaria Meyer IRCCS

SSID Oncoematologia pediatrica, Viale Gaetano Pieraccini 24, 50139, Florence

Azienda Ospedale-Universita Padova

UOC Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

Center of Pediatric Hematology Oncology, Via Santa Sofia 78, 95123, Catania

Ospedale Pediatrico Bambino Gesu'

Area Studi Clinici Oncoematologici e Terapie Cellulari, Piazza Sant'onofrio 4, 00165, Rome

Azienda Ospedaliero Universitaria Parma

UOC Pediatria e Oncoematologia, Dipartimento Materno-Infantile, Viale Antonio Gramsci 14, 43126, Parma

Azienda Ospedaliero Universitaria Delle Marche

SOsD Oncoematologia pediatrica Dipartimento Materno infantile, Via Conca 71, 60126, Ancona

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

S.S.D. Oncoematologia Pediatrica, Via Pietro Albertoni 15, 40138, Bologna

Azienda Ospedaliero Universitaria Di Modena

S.C. pediatria ad indirizzo onco-ematologicio, Largo Del Pozzo 71, 41124, Modena

Azienda Ospedaliera Universitaria Integrata Verona

UOC Oncoematologia Pediatrica, Piazzale Aristide Stefani 1, 37126, Verona

Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo

SC Oncoematologia Pediatrica, Via Dell' Istria 65/1, 34137, Trieste

Azienda Ospedaliero Universitaria Pisana

UO Oncoematologia Pediatrica, Via Roma 67, 56126, Pisa

ARNAS Civico Di Cristina Benfratelli

Oncoematologia pediatrica di Palermo, Piazza Nicola Leotta 4, 90127, Palermo

Fondazione IRCCS San Gerardo Dei Tintori

Clinica Pediatrica, Via Giovanni Battista Pergolesi 33, 20900, Monza

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

UOS Oncologia Pediatrica, Piazza Oms 1, 24127, Bergamo

Azienda Sanitaria Locale Di Pescara

Dipartimento Oncologico Ematologico, UOC di Ematologia - UO di Oncoematologia Pediatrica, Via Renato Paolini 47, 65124, Pescara

University Hospital Of Ferrara

DH Oncoematologia ped UO Clinica Pediatrica Dip Materno infantile, Cona, Via Aldo Moro 8, Ferrara

Azienda Socio Sanitaria Territoriale Dei Sette Laghi

Dipartimento Materno Infantile, Viale Luigi Borri N 57, 21100, Varese

University Hospital Consorziale Policlinico

D.A.I Scienze e Chirurgia Pediatriche U.O.C Pediatria ad Indirizzo Oncoematologico, Piazzale Giulio Cesare 11, 70124, Bari

Casa Sollievo Della Sofferenza

U.O.C di Oncoematologia Pediatrica, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo

Hospital Santa Maria Della Misericordia

Mother and Child Health, Piazzale Giorgio Menghini 1, 06129, Perugia

Azienda Unita Sanitaria Locale Della Romagna

SSID Oncoematologia pediatrica, Via Alcide De Gasperi 8, 48121, Ravenna

L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon

DIP.DI ONCOLOGIA, EMATOLOGIA E TERAPIE CELLULARI, Presidio Ospedaliero Santobono, Via Mario Fiore 6, Naples

Giannina Gaslini Institute For Scientific Hospitalization And Care

U.O.C. ONCOLOGIA - Dipartimento Emato-Oncologia, Via Gerolamo Gaslini 5, 16147, Genoa

ARNAS G. Brotzu

Area Medica, Piazzale Alessandro Ricchi 1, 09121, Cagliari

Fondazione IRCCS Policlinico San Matteo

S.C. Ematologia 2 - Oncoematologia Pediatrica, Viale Camillo Golgi 19, 27100, Pavia

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

DIPARTIMENTO PATOLOGIA E CURA DEL BAMBINO-SC Oncoematologia Pediatrica, Piazza Polonia 94, 10126, Turin

Netherlands

1 site · Ongoing, recruiting

Prinses Maxima Centrum voor Kinderoncologie B.V.

Hematooncology, Heidelberglaan 25, 3584 CS, Utrecht

Norway

4 sites · Ongoing, recruiting

St. Olavs Hospital HF

Pediatric, Ragnhilds Gate 15, 7030, Trondheim

Helse Bergen HF

Pediatric, Jonas Lies Vei 65, 5021, Bergen

Universitetssykehuset Nord-Norge HF

Pediatric, Sykehusvegen 38, 9019, Tromsoe

Oslo University Hospital HF

Pediatric, Taarnbygget, Kirkeveien 166, Oslo

Poland

16 sites · Ongoing, recruiting

Uniwersyteckie Centrum Kliniczne

Klinika Pediatrii, Hematologii i Onkologii, Ul. Debinki 7, 80-952, Gdansk

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach

Katedra i Klinika Pediatrii, Onkologii i Hematologii Dziecięcej, Ul. 3 Maja 13/15, 41-800, Zabrze

Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie

Klinika Onkohematologii Dziecięcej, Ul. Lwowska 60, 35-301, Rzeszow

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Katedra i Klinika Onkologii, Hematologii Dziecięcej, Transplantologii Klinicznej i Pediatrii, Ul. Zwirki I Wigury 63a, 02-091, Warsaw

Uniwersytecki Szpital Dzieciecy W Krakowie

Klinika Onkologii i Hematologii Dziecięcej Oddział Onkologii i Hematologii Dziecięcej, Ul. Wielicka 265, 30-663, Cracow

Uniwersytecki Szpital Dzieciecy W Lublinie

Klinika hematologii, Onkologii i Transplantologii Dziecięcej, Ul. Prof. Antoniego Gebali Nr 6, 20-093, Lublin

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie

Klinika Pediatrii, Hemato-Onkologii i Gastroenterologii Dziecięcej, Ul. Unii Lubelskiej 1, 71-252, Szczecin

Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy

Klinika Pediatrii, Hematologii i Onkologii, Ul. Marii Curie Sklodowskiej 9, 85-094, Bydgoszcz

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach

Oddział Onkologii, Hematologii i Chemioterapii, Ul. Medykow 16, 40-752, Katowice

Wojewodzki Specjalistyczny Szpital Dzieciecy Im Prof Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.;

Kliniczny Odział Onkologii i Hematologii Dziecięcej, Ul. Zolnierska 18 A, 10-561, Olsztyn

Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej

Klinika Pediatrii, Onkologii i Hematologii, Ul. Jerzego Waszyngtona 17, 15-269, Bialystok

Instytut Pomnik Centrum Zdrowia Dziecka

Klinika Onkologii, Aleja Dzieci Polskich 20, 04-730, Warsaw

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi

Klinika Pediatrii, Onkologii i Hematologii, Ul. Pomorska Nr 251, 92-213, Lodz

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej, Ul. Borowska 213, 50-556, Wroclaw

Wojewodzki Szpital Zespolony W Kielcach SPZOZ

II Klinika Pediatrii ,Oddział Onkologii i Hematologii Dziecięcej, Ul. Grunwaldzka 45, 25-736, Kielce

Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W Poznaniu

Klinika Onkologii, Hematologii i Transplantologii Pediatrycznej, Ul. Szpitalna 27/33, 60-572, Poznan

Slovakia

3 sites · Ongoing, recruiting

Detska Fakultna Nemocnica Kosice

Oddelenie detskej onkológie a hematológie, Trieda Snp 1, Zapad, Kosice

Detska Fakultna Nemocnica S Poliklinikou Banska Bystrica

Klinika pediatrickej onkológie a hematológie SZU, Namestie Ludvika Svobodu 4, 974 01, Banska Bystrica

Narodny Ustav Detskych Chorob

Klinika detskej hematológie a onkológie, Limbova 1, 833 40, Bratislava

Spain

30 sites · Ongoing, recruiting

Hospital General Universitario Gregorio Maranon

Pediatric oncology and hematology department, Calle Del Doctor Esquerdo 46, 28009, Madrid

Hospital Universitari Vall D Hebron

Pediatric oncology and hematology department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Hospital Universitario Donostia

Pediatrics, Pasealeku Doct. Begiristain 109, 20014, Donostia

Hospital Universitario De Badajoz

Pediatric oncology and hematology department, Avenida Elvas S/n, 06006, Badajoz

Hospital Universitario Regional De Malaga

Pediatric oncology, Avenida De Carlos De Haya Sn, 29010, Malaga

Hospital Unviersitario Miguel Servet

Pediatrics, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Complexo Hospitalario Universitario De Santiago

Pediatric oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela

Hospital De La Santa Creu I Sant Pau

Pediatric oncology and hematology department, Carrer De San Quinti 89, 08041, Barcelona

Hospital Universitario Central De Asturias

Pediatrics, Avenida De Roma S/n, 33011, Oviedo

Hospital Universitario Nuestra Senora De Candelaria

Pediatric oncology and hematology department, Carretera De Rosario 145, Resto, Santa Cruz De Tenerife

University Hospital Son Espases

Pediatrics, Carretera Valldemossa 79, 07120, Palma

Hospital Universitario Virgen De La Macarena

Pediatric oncology and hematology department, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Complexo Hospitalario Universitario De Vigo

Pediatric oncology, Estrada Clara Campoamor N 341, 36312, Vigo

Hospital Universitario Marques De Valdecilla

Pediatric oncology and hematology department, Avenida Valdecilla Sn, 39008, Santander

University Hospital Virgen Del Rocio S.L.

Pediatric oncology and hematology department, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitario Torrecardenas

Pediatrics, Calle Paraje Torrecardenas S/n, 04009, Almeria

Hospital Universitario 12 De Octubre

Pediatric oncology and hematology department, Bloque D, Avenida De Cordoba Sn, Madrid

Hospital Universitario De Navarra

Pediatric oncology, Irunlarrea Kalea 3, 31008, Pamplona

Hospital Clinico Universitario De Valencia

Pediatric oncology and hematology department, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital Clinico Universitario De Valladolid

Pediatric oncology and hematology department, Avenida Ramon Y Cajal 3, 47003, Valladolid

Hospital Universitario Y Politecnico La Fe

Pediatric oncology and hematology department, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Infantil Universitario Nino Jesus

Pediatric oncology and hematology department, Avenida Menendez Pelayo 65, 28009, Madrid

Sant Joan De Deu Barcelona Hospital

Pediatric oncology and hematology department, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat

Hospital Universitario Virgen De Las Nieves

Pediatric oncology and hematology department, Avenida De Las Fuerzas Armadas 2, 18014, Granada

Hospital Universitario De Toledo

Pediatrics, Avenue Del Rio Guadiana Sn, 45007, Toledo

Hospital Universitario De Cruces

Pediatric oncology and hematology department, Cruces Plaza S/n, 48903, Barakaldo

Hospital General Universitario Dr. Balmis

Pediatric oncology and hematology department, Avinguda Del Pintor Baeza 12, 03010, Alicante

Complejo Hospitalario Universitario Insular Materno Infantil

Pediatric oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria

University Clinical Hospital Virgen De La Arrixaca

Pediatrics, Carretera De Cartagena Sn, El Palmar, Murcia

Hospital Universitario La Paz

Pediatric oncology and hematology department, Paseo Castellana 261, 28046, Madrid

Sweden

6 sites · Ongoing, recruiting

Linkoping University Hospital Region Ostergotland

Pediatric Oncology, Universitetssjukhuset I Linkoping, 581 85, Linkoping

Region Vaesterbotten

Pediatric Oncology, Koksvagen 11, Alidhem, Umea

Karolinska University Hospital

Pediatric Oncology, Eugeniavagen 3, 171 64, Solna

Region Skane Skanes Universitetssjukhus

Pediatric Oncology, Entregatan 7, 222 42, Lund

Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen

Pediatric Oncology, Behandlingsvagen 7, Harlanda, Gothenburg

Uppsala University Hospital

Pediatric Oncology, P. O. Box 591, 751 24, Uppsala

Country notifications

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

Country	Trial start	Recruitment start
Austria	2019-08-01	2019-09-10
Belgium	2019-11-15	2020-06-12
Czechia	2019-10-21	2020-03-18
Denmark	2019-08-13	2019-10-21
Finland	2019-10-01	2020-09-28
Germany	2019-08-01	2019-08-23
Hungary	2023-06-19
Italy	2023-02-23	2023-10-10
Netherlands	2021-05-07	2021-06-24
Norway	2019-08-01	2019-10-09
Poland	2021-01-26	2022-01-27
Slovakia	2020-06-04	2023-02-20
Spain	2019-09-13	2020-03-02
Sweden	2019-09-13	2019-10-14

Results and documents

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

Documents 161 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol_2023-508101-24-00_redacted	2.0
Protocol (for publication)	D1_Protocol_DK_Appendix_2023-508101-24-00_redacted	5.0
Protocol (for publication)	D1_Protocol_IT_Appendix_2023-508101-24-00_redacted	1.6
Recruitment arrangements (for publication)	K1_ Recruitment arrangements Belgium	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements Denmark	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements explanatory note Hungary	1.0
Recruitment arrangements (for publication)	K1_ Recruitment arrangements Germany	1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements Netherlands	1.1
Recruitment arrangements (for publication)	K1_ Recruitment arrangements Slovakia	1
Recruitment arrangements (for publication)	K1_Recruitment arangements Sweden	1
Recruitment arrangements (for publication)	K1_Recruitment arrangement Czechia	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements Austria	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements Finland	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements Italy	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements Norway	1.6
Recruitment arrangements (for publication)	K1_Recruitment arrangements Poland	1.0
Recruitment arrangements (for publication)	K2_ Recruitment material Netherlands_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material movie Poland	1.0
Recruitment arrangements (for publication)	K2_Recruitment material poster Poland	1.0
Subject information and informed consent form (for publication)	Dine rettigheder som forsgsperson i forsg med medicin	1
Subject information and informed consent form (for publication)	L1_ ICF Biological samples over18yr Slovakia	1.0
Subject information and informed consent form (for publication)	L1_ ICF Biological samples parents Slovakia	1.0
Subject information and informed consent form (for publication)	L1_ICF 15-17 yr Finland_redacted	2.1
Subject information and informed consent form (for publication)	L1_ICF Italy 12-17yr	3
Subject information and informed consent form (for publication)	L1_ICF Italy over17yr	3.0
Subject information and informed consent form (for publication)	L1_ICF Italy parent-tutor	3.0
Subject information and informed consent form (for publication)	L1_ICF parents under15yr Finland_redacted	2.1
Subject information and informed consent form (for publication)	L1_ICF Sweden 15-18yr	2
Subject information and informed consent form (for publication)	L1_ICF under 15 yr Finland_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS 10-14 yr Finland_redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS 15-17 yr Finland_redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS 6-9 yr Finland_redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Add on projects 12-14yr Czech	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Add on projects 15-17yr Czech	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Add on projects 18yr Czech	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Add on projects parents Czech	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Austria adolescents redacted	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Austria children	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Austria childrenyounger	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Austria parents redacted	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Austria re-consent legal competence redacted	3.4
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium ENG 12-17yr_redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium ENG 8-11yr redacted	6.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium ENG over18yr_redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium ENG parents redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium FR 12-17yr redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium FR 8-11yr redacted	6.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium FR over18yr redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium FR parents redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium NL 12-17yr redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium NL 8-11yr redacted	6.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium NL over18yr redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Belgium NL parents redacted	8.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Czech 12-14yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Czech 15-17yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Czech 18yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Czech parents	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark 11-14 yr	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark 15-17 yr add on_redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark 15-17 yr_redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark 5-10 yr	1
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark adults add on_redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark adults_redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark parents add on_redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Denmark parents_redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany 12-15yr redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany 16-17yr redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany 8-11yr_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany over18yr_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany parents redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany re-consent legal competence redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany under8yr_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Germany_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Hungary 12-15yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Hungary 16-17yr_redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Hungary 8-11yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Hungary parents_redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Hungary under8yr	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Italy Privacy parent-tutor redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands 12-15 yr Randomisation 1 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands 12-15 yr Randomisation 2 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands over16yr Randomisation 1 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands over16yr Randomisation 2 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands Parents Randomisation 1 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Netherlands Parents Randomisation 2 redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Norway 12-16yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Norway adult redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Norway under12yr	1.3
Subject information and informed consent form (for publication)	L1_SIS and ICF parents Spain_ redacted	1.8
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland 13-15yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland 16-17yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland 8-12yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland adult redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland parents redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR 13-15yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR 16-17yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR 8-12yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR adult redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR parents redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland UKR under 8yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Poland under 8yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Slovakia 12-14yr	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Slovakia 15-17yr	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Slovakia over18yr	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Slovakia parents	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Spain 12-17yr_redacted	1.8
Subject information and informed consent form (for publication)	L1_SIS and ICF Spain re-consent legal competence_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF supplement parents Germany_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Sweden 12-14yr redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Sweden 6-11yr redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF Sweden over18yr redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Italy Privacy over17yr redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 10-14yr R1-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 10-14yr R2-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 15-17yr R1-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 15-17yr R2-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 6-9yr R1-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland 6-9yr R2-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland parents R1-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Finland parents R2-Randomisation	2.0
Subject information and informed consent form (for publication)	L1_SIS Italy 12-17yr	3.0
Subject information and informed consent form (for publication)	L1_SIS Italy over17yr	3.0
Subject information and informed consent form (for publication)	L1_SIS parents Finland_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS parents of 15-17 yr Finland_redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS Sweden 15-18yr redacted	2
Subject information and informed consent form (for publication)	L1_SIS Sweden parents redacted	2
Subject information and informed consent form (for publication)	L1_SIS_GDPR parents patient Czech_redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS_Italy parent-tutor	3
Subject information and informed consent form (for publication)	L2_ pregnancy information A parents	1
Subject information and informed consent form (for publication)	L2_ pregnancy information DE 12-17yr	1
Subject information and informed consent form (for publication)	L2_ pregnancy information DE parents	1
Subject information and informed consent form (for publication)	L2_ pregnany information A 12-17yr	1
Subject information and informed consent form (for publication)	L2_letter to treating physician_Italy	3.0
Subject information and informed consent form (for publication)	L2_SIS and ICF Austria contacts redacted	3.4b
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Cyclophosphamide	1
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Cytarabine	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Daunorubicin	1
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Dexamethasone	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Doxorubicin	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Ifosfamide	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Mercaptopurine	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Methotrexate	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Pegaspargase	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Prednisolone	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Prednisone	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Tioguanine	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Vincristine	2
Summary of Product Characteristics (SmPC) (for publication)	E1_SmPC Vindesine	1
Synopsis of the protocol (for publication)	D1_ Protocol synopsis_NL_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis IT 2023-508101-24	4.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_AT_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_2023-508101-24_EN_redacted	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_2023-508101-24_FR_redacted	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_BE_2023-508101-24_NL_redacted	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_CZ_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ES_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_NO_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_PL_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol_synopsis_SE_2023-508101-24	2.0
Synopsis of the protocol (for publication)	D1_Protocol_synopsis_SK_2023-508101-24	2.0

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-03-04	Germany	Acceptable 2024-04-09	2024-04-09
2	SUBSTANTIAL MODIFICATION	SM-4	2025-04-22	Germany	Acceptable 2025-06-18	2025-06-18
3	SUBSTANTIAL MODIFICATION	SM-5	2025-07-28		Acceptable	2025-09-15
4	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-09-17			2025-09-17
5	SUBSTANTIAL MODIFICATION	SM-6	2025-10-07		Acceptable	2025-11-24
6	SUBSTANTIAL MODIFICATION	SM-8	2025-11-19		Acceptable	2026-01-19
7	SUBSTANTIAL MODIFICATION	SM-9	2025-12-10		Acceptable	2026-01-22
8	SUBSTANTIAL MODIFICATION	SM-7	2025-12-15		Acceptable	2026-01-23
9	SUBSTANTIAL MODIFICATION	SM-10	2026-01-28	Germany	Acceptable	2026-02-03
10	SUBSTANTIAL MODIFICATION	SM-11	2026-02-27		Acceptable	2026-03-30
11	SUBSTANTIAL MODIFICATION	SM-12	2026-03-23	Germany	Acceptable	2026-03-27
12	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-04-08	Germany	Acceptable	2026-04-08

LBL 2018 - International cooperative treatment protocol for children and adolescents with lymphoblastic lymphoma