International trial in Philadelphia chromosome-positive acute lymphoblastic leukemia

2024-515499-12-00 Protocol EsPhALL2017/COGAALL1 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 2 Oct 2017 · Status Ongoing, recruitment ended · 12 EU/EEA countries · 167 sites · Protocol EsPhALL2017/COGAALL1

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 306
Countries 12
Sites 167

Acute lymphoblastic leukemia

To compare disease-free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a highrisk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

Key facts

Sponsor
Universita Degli Studi Di Milano Bicocca
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
2 Oct 2017 → ongoing
Decision date (initial)
2024-10-29
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-515499-12-00
EudraCT number
2017-000705-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

To compare disease-free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a highrisk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

Conditions and MedDRA coding

Acute lymphoblastic leukemia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

  1. 1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol.
  2. 2. > 1 year and < 21 years at ALL diagnosis
  3. 3. New LLA diagnosis a. type B or T, or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or RT-PCR b. type B, with definitive evidence of ABL class fusions identified according to National/Center procedures of each participating country.
  4. 4. Prior Therapy for BCR-ABL1 fusion patients: a. induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-Asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy. b. Not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine. c. May have started imatinib prior to study entry but have not received more than 14 days of imatinib.
  5. 5. Prior Therapy for ABL-class fusion patients: a. must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy. b. may have started imatinib during Induction IA, at the same time of or after the first vincristine dose.
  6. 6. Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2.
  7. 7. Adequate liver function.
  8. 8. Adequate cardiac function.
  9. 9. Adequate renal function.

Exclusion criteria 9

  1. 1. Known history of chronic myelogenous leukemia (CML).
  2. 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy.
  3. 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
  4. 4. Down syndrome
  5. 5. Pregnancy
  6. 6. Breast Feeding
  7. 7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol.
  8. 8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block.
  9. 9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events
  2. The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events
  3. The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events
  4. The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events

Investigational products

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

Test 20

Decortin H 5 mg töflur

PRD338895 · Product

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
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
840 mg/m2 milligram(s)/square meter
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
IS/1/04/101/01
MA holder
MERCK AB
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dexamethasone

SUB07017MIG · Substance

Active substance
Dexamethasone
Pharmaceutical form
TABLET
Route of administration
ORAL AND IV
Max daily dose
20 mg/m2 milligram(s)/square meter
Max total dose
860 mg/m2 milligram(s)/square meter
Max treatment duration
110 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Daunorubicin Hydrochloride

SUB01556MIG · Substance

Active substance
Daunorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
30 mg/m2 milligram(s)/square meter
Max total dose
80 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristina Teva Italia 1 mg/ml soluzione iniettabile

PRD2164507 · Product

Active substance
Vincristine Sulfate
Pharmaceutical form
INJECTION
Route of administration
INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
36 mg/m2 milligram(s)/square meter
Max treatment duration
24 Day(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
038549010
MA holder
TEVA ITALIA S.R.L.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Imatinib

SUB25387 · Substance

Active substance
Imatinib
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
800 mg milligram(s)
Max total dose
584000 mg milligram(s)
Max treatment duration
730 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

DELTACORTENE 25 mg compresse

PRD349593 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL AND IV
Max daily dose
60 mg/m2 milligram(s)/square meter
Max total dose
840 mg/m2 milligram(s)/square meter
Max treatment duration
2 Week(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
010089035
MA holder
BRUNO FARMACEUTICI
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SUB07337MIG · Substance

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
200 mg/m2 milligram(s)/square meter
Max total dose
500 mg/l milligram(s)/litre
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Route of administration
INTRAVENOUS, INTRA-ARTERIAL, INTRATHECAL USE
Max daily dose
12 mg milligram(s)
Max total dose
216 mg milligram(s)
Max treatment duration
18 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
30 mg/m2 milligram(s)/square meter
Max total dose
1500 mg/m2 milligram(s)/square meter
Max treatment duration
16 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
5000 mg/m2 milligram(s)/square meter
Max total dose
21000 mg/m2 milligram(s)/square meter
Max treatment duration
9 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Doxorubicin Hydrochloride

SUB01827MIG · Substance

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
25 mg/m2 milligram(s)/square meter
Max total dose
200 mg/m2 milligram(s)/square meter
Max treatment duration
8 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tioguanine

SUB11084MIG · Substance

Active substance
Tioguanine
Pharmaceutical form
TABLET
Route of administration
ORAL USE
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
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION OR INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
30 mg milligram(s)
Max total dose
90 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine

SUB06880MIG · Substance

Active substance
Cytarabine
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INJECTION
Max daily dose
4000 mg/m2 milligram(s)/square meter
Max total dose
14400 mg/m2 milligram(s)/square meter
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ifosfamide

SUB08125MIG · Substance

Active substance
Ifosfamide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INFUSION
Max daily dose
1600 mg/m2 milligram(s)/square meter
Max total dose
4000 mg/m2 milligram(s)/square meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mercaptopurine

SUB12149MIG · Substance

Active substance
Mercaptopurine
Pharmaceutical form
TABLETS
Route of administration
ORAL USE
Max daily dose
75 mg/m2 milligram(s)/square meter
Max total dose
40500 mg/m2 milligram(s)/square meter
Max treatment duration
18 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pegaspargase

SUB03666MIG · Substance

Active substance
Pegaspargase
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
2500 m2 square meter
Max total dose
12500 m2 square meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cyclophosphamide

SUB06859MIG · Substance

Active substance
Cyclophosphamide
Pharmaceutical form
INJECTION/INFUSION
Route of administration
INJECTION
Max daily dose
1 mg/m2 milligram(s)/square meter
Max total dose
5 mg/m2 milligram(s)/square meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hydrocortisone Sodium Succinate

SUB02569MIG · Substance

Active substance
Hydrocortisone Sodium Succinate
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
12 mg milligram(s)
Max total dose
36 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Erwinase 10 000 U polvere per soluzione iniettabile/per infusione.

PRD10892599 · Product

Active substance
Crisantaspase
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
40000 IU international unit(s)
Max total dose
1400000 IU international unit(s)
Max treatment duration
10 Week(s)
Authorisation status
Authorised
ATC code
L01XX02 — ASPARAGINASE
Marketing authorisation
050520016
MA holder
PORTON BIOPHARMA LIMITED
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita Degli Studi Di Milano Bicocca

5 Total trials 2 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Universita Degli Studi Di Milano Bicocca
Address
Piazza Dell'ateneo Nuovo 1
City
Milan
Postcode
20126
Country
Italy

Scientific contact point

Organisation
Universita Degli Studi Di Milano Bicocca
Contact name
Study PI

Public contact point

Organisation
Universita Degli Studi Di Milano Bicocca
Contact name
Scientific coordinator

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

12 EU/EEA countries · 167 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 6 5
Belgium Ongoing, recruitment ended 6 6
Czechia Ongoing, recruitment ended 18 3
Denmark Ongoing, recruitment ended 6 3
Finland Ongoing, recruitment ended 6 5
France Ongoing, recruitment ended 66 28
Germany Ongoing, recruitment ended 72 54
Italy Ongoing, recruitment ended 48 26
Netherlands Ongoing, recruitment ended 18 1
Poland Ongoing, recruitment ended 24 15
Spain Ongoing, recruitment ended 24 16
Sweden Ongoing, recruitment ended 12 5
Rest of world — 0 —

Investigational sites

Austria

5 sites · Ongoing, recruitment ended
St. Anna Kinderspital GmbH
Onkologie, Kinderspitalgasse 6, Alsergrund, Vienna
Medical University Of Graz
Klinische Abteilung für pädiatrische Hämato-Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
Pädiatrie I, Anichstrasse 35, 6020, Innsbruck
Kepler Universitaetsklinikum GmbH
Med Campus IV/Onkologie, Krankenhausstrasse 7a, 4020, Linz
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Kinderonkologie, Muellner Hauptstrasse 48, 5020, Salzburg

Belgium

6 sites · Ongoing, recruitment ended
Cliniques Universitaires Saint-Luc
Hématologie et oncologie pédiatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Pediatrische hemato-oncologie, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Regional De La Citadelle
Hémato - oncologie pédiatrique, Boulevard Du Douzieme De Ligne 1, 4000, Liege
CHC MontLegia
Hémato - oncologie pédiatrique, Boulev. De Patience Et Beajonc 2, 4000, Liege
UZ Leuven
Kinderhemato-oncologie, Herestraat 49, 3000, Leuven
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Pédiatrie hémato-oncologie, Jean Joseph Crocqlaan 15, 1020, Brussels

Czechia

3 sites · Ongoing, recruitment ended
Fakultni Nemocnice V Motole
Department of Pediatric Hematology and Oncology, V Uvalu 84/1, Motol, Prague
University Hospital Olomouc
Department of Pediatrics, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Department of Pediatric Oncology, Cernopolni 9, Cerna Pole, Brno-Sever

Denmark

3 sites · Ongoing, recruitment ended
Rigshospitalet
Department of Paediatric and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
The Hans Christian Andersen Childrens Hospital, J B Winsloews Vej 4, 5000, Odense C
Aarhus Universitetshospital
Department of Paediatric and Adolescent Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Finland

5 sites · Ongoing, recruitment ended
Pohjois-Savon hyvinvointialue
Department of Pediatric Hematology and Oncology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
Varsinais-Suomen hyvinvointialue
Department of Pediatric Hematology and Oncology, Kiinamyllynkatu 4-8, 20520, Turku
Pohjois-Pohjanmaan hyvinvointialue
Department of Pediatric Hematology and Oncology, Kajaanintie 50, 90220, Oulu
HUS-Yhtymae
Department of Pediatric Hematology and Oncology, Stenbackinkatu 9, 00290, Helsinki
Pirkanmaan hyvinvointialue
Department of Pediatric Hematology and Oncology, Elamanaukio 2, 33520, Tampere

France

28 sites · Ongoing, recruitment ended
Les Hopitaux Universitaires De Strasbourg
Paediatric haematology oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Paris
Hématologie Pédiatrie, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire D'Angers
Paediatric haematology oncology, 4 Rue Larrey, 49100, Angers
Assistance Publique Hopitaux De Paris
Paediatric haematology oncology, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Universitaire Amiens Picardie
Paediatric onco-haematology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
University Hospital Of Clermont-Ferrand
Paediatric haematology oncology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Regional De Marseille
Haemato-Onco-Pediatrics, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Montpellier
Haemato-Onco-Pediatrics, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
CHU Besancon
Paediatric haematology oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Nice
Paediatric Haematology Oncology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Dijon
Paediatric onco-haematology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Toulouse
Paediatric haematology oncology, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Paediatric haematology oncology, 49 Boulevard Beranger, 37000, Tours
Centre Hospitalier Universitaire De Saint Etienne
Paediatric haematology oncology, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Hospices Civils De Lyon
Paediatric haematology, 1 Place Professeur Joseph Renaut, 69008, Lyon
Centre Hospitalier Universitaire De Bordeaux
Paediatric haematology oncology, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Poitiers
Paediatric onco-haematology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire Reims
Paediatric haematology oncology, 45 Rue Cognacq Jay, 51092, Reims Cedex
Centre Hospitalier Universitaire Rouen
Paediatric haematology oncology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Caen Normandie
Paediatric haematology oncology, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier Regional Et Universitaire De Brest
Paediatric haematology oncology, 2 Avenue Marechal Foch, 29200, Brest
CHRU De Nancy
Paediatric haematology oncology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Rennes
Paediatric haematology oncology, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Centre Hospitalier Universitaire Grenoble Alpes
Paediatric haematology oncology, Quai Yermoloff, 38700, La Tronche
Centre Hospitalier Et Universitaire De Limoges
Paediatric haematology oncology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De La Reunion
Paediatric oncology, Allee Des Topazes, Cs 11021, Saint-Denis
Centre Hospitalier Universitaire De Lille
Paediatric haematology oncology, Avenue Eugene Avinee, 59037, Lille Cedex
Centre Hospitalier Universitaire De Nantes
Paediatric haematology oncology, 7 Quai Moncousu, 44000, Nantes

Germany

54 sites · Ongoing, recruitment ended
Carl-Thiem-Klinikum Cottbus gGmbH
Pädiatrische Onkologie und Hämatologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Universitaetsmedizin Goettingen
Abt. Pädiatrische Hämatologie und Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Essen AöR
Zentrum für Kinder- und Jugendmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Staedtisches Klinikum Braunschweig gGmbH
Zentrum für Kinder- und Jugendmedizin, Salzdahlumer Strasse 90, Suedstadt, Brunswick
Universitaet Leipzig
Department für Frauen- und Kindermedizin, selbstständige Abteilung für Pädiatrische Onkologie, Hämat, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Ulm AöR
Klinik für Kinder-und Jugendmedizin , Pädiatrische Hämatologie und Onkologie,, Eythstrasse 24, Mitte, Ulm
Universitaetsklinikum Regensburg AöR
Kinderklinik, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Medizinische Hochschule Hannover
Zentrum Kinderheilkunde und Jugendmedizin, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Kinder- und Jugendmedizin, Schwanebecker Chaussee 50, Buch, Berlin
Klinikum der Universitaet Muenchen AöR
Klinik für Kinder und Jugendmedizin, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Staedtisches Klinikum Karlsruhe gGmbH
Pädiatrische Onkologie und Hämatologie, Moltkestrasse 90, Weststadt, Karlsruhe
Otto Von Guericke Universitaet Magdeburg
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Kinder und Jugendmedizin, Kriegsbergstrasse 62, Mitte, Stuttgart
Klinik Hallerwiese - Cnopfsche Kinderklinik
Pädiatrische Onkologie und Hämatologie, St Johannis Muehlgasse 19, 90419, Nuernberg
Kliniken der Stadt Koeln gGmbH
Kinderkrankenhaus, Amsterdamer Strasse 59, Riehl, Cologne
Justus-Liebig-Universitaet Giessen
Zentrum für Kinderheilkunde und Jugendmedizin,Abt. Pädiatrische Hämatologie / Onkologie, Feulgenstrasse 10-12, 35392, Giessen
Klinikum Kassel GmbH
Kinderklinik f. päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Evangelisches Klinikum Bethel gGmbH
Kinderklinik, Päd. Hämatologie/Onkologie, Kantensiek 11, Gadderbaum, Bielefeld
Universitaetsklinikum Tuebingen AöR
Abteilung Kinderheilkunde I mit Poliklinik, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaet Des Saarlandes
Pädiatrische Onkologie und Hämatologie, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Mannheim GmbH
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Augsburg
"Schwäbisches Kinderkrebszentrum Kinderkrebsforschungszentrum", Stenglinstrasse 2, Kriegshaber, Augsburg
University Medical Center Hamburg-Eppendorf
Abt. Pädiat. Hämatologie und Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Goethe University Frankfurt
Klinik für Kinder und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Wuerzburg AöR
Kinderklinik - Onkologische Tagesklinik, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Klinikum Dortmund gGmbH
Klinik für Kinder- und Jugendmedizin, Beurhausstrasse 40, Mitte, Dortmund
Charite Universitaetsmedizin Berlin KöR
Klinik f. Pädiatrie m. S. Onkolgie/Hämatologie, Augustenburger Platz 1, Wedding, Berlin
HELIOS Klinikum Erfurt GmbH
Kinderonkologisches Zentrum, Klinik für Kinder- und Jugendmedizin, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
HELIOS Kliniken Schwerin GmbH
Klinik für Kinder und Jugendmedizin, Wismarsche Strasse 393-397, 19049, Schwerin
Universitaetsklinikum Heidelberg AöR
Hopp-Kindertumorzentrum Heidelberg (KiTZ), Im Neuenheimer Feld 430, Neuenheim, Heidelberg
Gemeinschaftskrankenhaus Herdecke gGmbH
Pädiatrische Onkologie und Hämatologie, Gerhard-Kienle-Weg 4, Westende, Herdecke
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Zentrum f. Kinder- und Jugendmedizin, Langenbeckstrasse 1, Oberstadt, Mainz
Gesundheit Nord gGmbH Klinikverbund Bremen
Kinderonkologisches Zentrum-Station 3, Haus 4, Ebene 2, St.-Juergen-Strasse 1, Hulsberg, Bremen
Asklepios Klinik Sankt Augustin GmbH
Klinik für Kinder und Jugendmedizin, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Klinikum Oldenburg AöR
Pädiatrische Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Klinikum rechts der Isar der TU Muenchen AöR
Kinderklinik München Schwabing, Koelner Platz 1, Schwabing-West, Munich
Klinikum Wolfsburg
Pädiatrische Onkologie und Hämatologie, Sauerbruchstrasse 7, Klieversberg, Wolfsburg
Universitaetsklinikum Jena KöR
Pädiatrische Hämatologie und Onkologie, Am Klinikum 1, Lobeda, Jena
University Hospital Cologne AöR
Klinik und Poliklinik für Kinder- und Jugendmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Duesseldorf AöR
Klinik für Kinder- Onkologie, Moorenstrasse 5, Bilk, Duesseldorf
Gemeinschaftsklinikum Mittelrhein gGmbH
Klinik für Kinder und Jugendmedizin, Koblenzer Str 115-155, 56073, Koblenz
Universitaetsklinikum Erlangen AöR
Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie, Loschgestrasse 15, Innenstadt, Erlangen
Rheinische Friedrich-Wilhelms-Universitaet Bonn
Zentrum für Kinderheilkunde, Venusberg-Campus 1, Venusberg, Bonn
Technische Universitaet Dresden
Klinik und Poliklinik für Kinder- und Jugendmedizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
Klinik für Kinder und Jugendmedizin, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Universitaetsmedizin Greifswald KöR
Pädiatrische Onkologie und Hämatologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Muehlenkreiskliniken AöR
Universitätsklinik für Kinder- und Jugendmedizin, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
SLK-Kliniken Heilbronn GmbH
Kinder- und Jugendmedizin mit Perinatalzentrum, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinder und Jugendmedizin, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinder- und Jugendmedizin I, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Aachen AöR
Sektion Pädiatrische Hämatologie, Onkologie u. Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
Rostock University Medical Center
Universitäts-Kinder- und Jugendklinik K1, Schillingallee 35, Hansaviertel, Rostock
Martin-Luther-Universitaet Halle-Wittenberg
Pädiatrie I, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaet Muenster
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster

Italy

26 sites · Ongoing, recruitment ended
Azienda Ospedaliero Universitaria Delle Marche
Oncoematologia pediatrica, Via Conca 71, 60126, Ancona
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
SC Oncoematologia Pediatrica, Via Dell' Istria 65/1, 34137, Trieste
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
UOS Oncologia Pediatrica, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera di Padova
UOC Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova
University Of Bari Aldo Moro
U.O.C Pediatria ad Indirizzo Oncoematologico, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Santobono Pausilipon
DIP.DI ONCOLOGIA, EMATOLOGIA E TERAPIE CELLULARI, Via Posillipo 226, 80123, Naples
Azienda Ospedaliera Universitaria Meyer IRCCS
SOC Oncologia, Ematologia, TCSE e Terapia Genica, Viale Gaetano Pieraccini 24, 50139, Florence
ARNAS G. Brotzu
S.C. Oncoematologia pediatrica, Piazzale Alessandro Ricchi 1, 09121, Cagliari
IRCCS Istituto Giannina Gaslini
U.O.C. ONCOLOGIA - Dipartimento Emato-Oncologia, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Sanitaria Locale Di Pescara
UO di Oncoematologia Pediatrica, Via Renato Paolini 47, 65124, Pescara
Fondazione IRCCS San Gerardo Dei Tintori
SC Pediatria, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Di Modena
U.O. Oncoematologia pediatrica, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Center of Pediatric Hematology Oncology, Via Santa Sofia 78, 95123, Catania
Hospital Santa Maria Della Misericordia
S.C. Oncoematologia pediatrica con TCSE, Piazzale Giorgio Menghini 1, 06129, Perugia
Universita' Degli Studi Di Verona
UOC Oncoematologia Pediatrica, Piazzale Aristide Stefani 1, 37126, Verona
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
Azienda Ospedaliero Universitaria Parma
UOC Pediatria e Oncoematologia, Viale Antonio Gramsci 14, 43126, Parma
Ospedale Pediatrico Bambino Gesu
Area Studi Clinici Oncoematologici e Terapie Cellulari, Piazza Di Sant'onofrio 4, 00165, Rome
European Hematology Association
Dipartimento di Medicina Traslazionale e di Precisione, Via Benevento 6, 00161, Rome
Fondazione IRCCS Policlinico San Matteo
S.C. Ematologia 2 - Oncoematologia Pediatrica, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliera-Universitaria Di Cosenza
U.O.C. Oncoematologia pediatrica, Via Felice Migliori 1, 87100, Cosenza
Azienda Ospedaliero Universitaria Renato Dulbecco
S.O.C. ematologia e oncologia pediatrica, Viale Pio X 95, 88100, Catanzaro
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
S.C.oncoematologia pediatrica e TMO, Piazzale Spedali Civili 1, 25123, Brescia
Casa Sollievo Della Sofferenza
U.O.C di Oncoematologia Pediatrica, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncoematologia Pediatrica, Via Pietro Albertoni 15, 40138, Bologna
Seconda Universita Di Napoli
U.P. "Terapie innovative in Oncologia Pediatrica", Vico Luigi De Crecchio 7, 80138, Naples

Netherlands

1 site · Ongoing, recruitment ended
Prinses Maxima Centrum voor Kinderoncologie B.V.
Pediatrics, Heidelberglaan 25, 3584 CS, Utrecht

Poland

15 sites · Ongoing, recruitment ended
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 Dzieciecy W Krakowie
Klinika Onkologii i Hematologii Dziecięcej, Ul. Wielicka 265, 30-663, Cracow
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 Hematologii, Onkologii i Transplantologii Dziecięcej, Ul. Prof. Antoniego Gebali Nr 6, 20-093, Lublin
Medical University Of Silesia Katowice Poland
Klinika Pediatrii, Hematologii i Onkologii, Medykow 16, 40-752, Katowice
Wojewodzki Szpital Zespolony W Kielcach SPZOZ
Oddział Onkologii i Hematologii Dziecięcej, Ul. Grunwaldzka 45, 25-736, Kielce
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Pediatrii, Onkologii i Hematologii, Ul. Jerzego Waszyngtona 17, 15-269, Bialystok
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
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Oddział Kliniczny Pediatrii, Hematologii i Onkologii, Ul. Zwirki I Wigury 63a, 02-091, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Klinika Pediatrii, Hemato-Onkologii i Gastroenterologii Dziecięcej, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Ponadregionalne Centrum Onkologii Dziecięcej "Przylądek Nadziei", Ul. Borowska 213, 50-556, Wroclaw
Wojewodzki Specjalistyczny Szpital Dzieciecy Im. Prof. Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.
Oddział Kliniczny Onkologii i Hematologii Dziecięcej, Ul. Zolnierska 18 A, 10-561, Olsztyn
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
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Klinika Onkohematologii Dziecięcej, Ul. Lwowska 60, 35-301, Rzeszow
Uniwersyteckie Centrum Kliniczne
Klinika Pediatrii, Hematologii i Onkologii, Ul. Debinki 7, 80-211, Gdansk

Spain

16 sites · Ongoing, recruitment ended
Hospital Universitario Regional De Malaga
pediatric oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
pediatric oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Cruces
pediatric oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Marques De Valdecilla
pediatric oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Sant Joan De Deu Barcelona
pediatric oncology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital General Universitario Gregorio Maranon
pediatric oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
pediatric oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
pediatric oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
pediatric oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario La Paz
pediatric oncology, Paseo De La Castellana 261, 28046, Madrid
University Hospital Son Espases
pediatric oncology, Carretera Valldemossa 79, 07120, Palma
Hospital Infantil Universitario Nino Jesus
pediatric oncology, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital General Universitario Dr. Balmis
pediatric oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
University Clinical Hospital Virgen De La Arrixaca
pediatric oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Complejo Hospitalario Universitario Insular Materno Infantil
pediatric oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Miguel Servet
pediatric oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Sweden

5 sites · Ongoing, recruitment ended
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Sahlgrenska, Behandlingsvagen 7, Harlanda, Gothenburg
Uppsala University Hospital
Children Oncology Unit, Akademiska Sjukhuset, 751 85, Uppsala
Region Oestergoetland
H.R.H.Crown Princess Victorias Children Hospital, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Karolinska University Hospital
Children Oncology Unit, Kirurgigaten 53, 141 86, Stockholm
Region Skane Skanes Universitetssjukhus
Pediatric oncology and hematology, Entregatan 7, 222 42, Lund

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 2019-04-04 2020-04-16 2024-09-30
Belgium 2020-06-26 2021-02-09 2024-09-30
Czechia 2018-10-08 2018-11-07 2024-09-30
Denmark 2021-07-09 2022-04-22 2024-09-30
Finland 2019-06-14 2020-08-07 2024-09-30
France 2019-07-08 2019-07-25 2024-09-30
Germany 2019-01-15 2019-01-15 2024-09-30
Italy 2017-10-02 2017-10-02 2024-09-30
Netherlands 2018-07-17 2018-11-09 2024-09-30
Poland 2021-03-11 2021-05-07 2024-09-30
Spain 2021-06-29 2021-08-17 2024-09-30
Sweden 2020-09-23 2021-03-17 2024-09-30

Results and documents

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

Documents 166 files

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

TypeTitleVersion
Protocol (for publication) D1_Consolidated protocol 2024-515499-12-00_redacted 3.1
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1.2
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition N/A
Recruitment arrangements (for publication) K1_ Recruitment arrangements_blank document transition 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_ancillari_Genitori 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_ancillari_Maggiorenni 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_Induzione_genitori 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_Post Induzione HR 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_Post Induzione HR_maggiorenni 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_Post Induzione SR_ genitori 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF Italia_Post Induzione SR_maggiorenni 1.0
Subject information and informed consent form (for publication) L1_EsPhALL2017-AALL1631_ICF_Contacts_Austria 20230217
Subject information and informed consent form (for publication) L1_EsPhALL2017-AALL1631_ICF_Contacts_Austria_redacted 20230217
Subject information and informed consent form (for publication) L1_IS and ICF_Induction_parents_legal guardians 3
Subject information and informed consent form (for publication) L1_IS and ICF_Post-Induction HR_parents_legal guardians 3.0
Subject information and informed consent form (for publication) L1_IS and ICF_Post-Induction SR_parents_legal guardians 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF SR_13-17 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF SR_7-12 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF SR_Parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF - SR - Unge 15-17 samtykke _Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF ENG_12-17y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF ENG_12-17y_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF ENG;18y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF ENG;18y_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF HR_13-17 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF HR_7-12 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF HR_Adult Patient 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF HR_Parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Induction_7-12 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ jongeren va 16jr SR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ kinderen 12-15jr HR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ kinderen 12-15jr Induction_REDACTED 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ kinderen 12-15jr SR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ ouders HR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ ouders Induction_REDACTED 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_ ouders SR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_jongeren va 16jr HR_REDACTED 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Olanda_jongeren va 16jr Induction_REDACTED 5.0
Subject information and informed consent form (for publication) L1_SIS and ICF SR_Adult Patient 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ ENG_children 8_11y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ ENG_parents_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ FR ;18y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ FR_12-17y_redacted 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_ HR - 18;samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ HR - 18;samtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ Induktion - 18;samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ Induktion - Forldresamtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ Induktion - Unge 15-17 samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ SR - 18;samtykke _Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ SR - Forldresamtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ SR - Forldresamtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ SR - Unge 15-17 samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adolescents_Hochrisikogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adolescents_Induktion_redacted 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adolescents_Standardriskogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adults_Hochrisikogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adults_Induktion_redacted 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Adults_Standardriskogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Older children_Induktion und Postinduktion 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Parents_Hochrisikogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Parents_Induktion_redacted 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Parents_Standardriskogruppe 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF_Austria_Younger children_Induktion und Postinduktion 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF_ENG_children 8_11y_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ENG_parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Information sheet_parent 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus _15-17 vaihe 2;HUOLTAJA korkearisk 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus _15-17 vaihe 2;HUOLTAJA vakioriski 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus _HUOLTAJA 0-14 v_vaihe 2 vakioriski 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus_EsPHALL2017 15-17 vaihe 1; HUOLTAJA 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus_EsPHALL2017 HUOLTAJA 0-14 v_vaihe 1 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Suostumus_EsPHALL2017 HUOLTAJA 0-14 v_vaihe 2 korkeariski 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Tiedote ja suostumus_EsPhALL2017_11-14 vaihe 1 ja 2 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Tiedote ja suostumus_EsPhALL2017_6-10 vaihe 1 ja 2 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Finlandia_Tiedote_EsPhALL2017_15-17 vuotias 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_12-17y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_enfants 8_11ans 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_enfants 8_11ans_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_parents_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR;18y_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Germany_redacted 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_HR - Forldresamtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_HR - Forldresamtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_HR - Unge 15-17 samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_HR - Unge 15-17 samtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Induction_13-17 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Induction_Adult Patient 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Induction_Parents 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Induktion - 18;samtykke_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Induktion - Forldresamtykke 1.2
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Subject information and informed consent form (for publication) L1_SIS and ICF_NL_ouders_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_NL;18y 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_NL;18y_redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Indukce Informace pro pacienty pod 8 let_cz N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Indukce_ICF_ 8-15let_Am2_cz 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Indukce_ICF_15-17 let_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Indukce_ICF_nad 18_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Indukce_ICF_rodie_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postind_HR_ICF_15-17_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postind_HR_ICF_8-15_Am2_cz 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postind_HR_ICF_nad18_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postind_HR_ICF_rodi_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postindu SR Informace pro pacienty pod 8 let_cz N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postindu_HR Informace pro pacienty pod 8 let_cz N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postindu_SR_ICF_15-17_Am2_cz 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF_REPCECA_Postindu_SR_ICF_8-15_Am2_cz 2.0
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Subject information and informed consent form (for publication) L1_SIS and ICF_Spagna_12-17yr_redact 3
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Subject information and informed consent form (for publication) L1_SIS and ICF_Spagna_Induction18 yr_redact 3
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Subject information and informed consent form (for publication) L1_SIS and ICF_Spagna_Post-Induction SR 12-17 yr_redact 3
Subject information and informed consent form (for publication) L1_SIS and ICF_Spagna_Post-Induction SR legal representative_redact 3
Subject information and informed consent form (for publication) L1_SIS and ICF_SR - 18;samtykke 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Svezia_Participant inf _VARDNADSHAVARE 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Svezia_Patient inf 10-15ar 1
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Subject information and informed consent form (for publication) L1_SIS_Induction_under 11 yr 2.0
Subject information and informed consent form (for publication) L1_SIS_Post-Induction HR_11-15 yr 2.0
Subject information and informed consent form (for publication) L1_SIS_Post-Induction HR_under 11 yr 2.0
Subject information and informed consent form (for publication) L1_SIS_Post-Induction SR_11-15 yr 2.0
Subject information and informed consent form (for publication) L1_SIS_Post-Induction SR_under 11 yr 2.0
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Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-18 Italy Acceptable
2024-10-24
 2024-10-25

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