Clinical trial • Not applicable • Oncology|Haematology

FLUDARABINE PHOSPHATE for Acute lymphoblastic leukaemia

Not applicable trial of FLUDARABINE PHOSPHATE for Acute lymphoblastic leukaemia.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Acute lymphoblastic leukaemia
Trial Stage
Not applicable
Drug Modality
Small molecule|Other antibody|Bispecific antibody
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-09-2024
First CTIS Authorization Date
09-10-2024

Trial design

Randomised, etoposide — comparator (product name etoposide). dose information provided in part i: max daily dose 60 mg/kg (dose unit mg/kg). used as part of the tbi/etoposide conditioning comparator regimen.-controlled Not applicable trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
ETOPOSIDE — comparator (product name ETOPOSIDE). Dose information provided in Part I: max daily dose 60 mg/kg (dose unit mg/kg). Used as part of the TBI/Etoposide conditioning comparator regimen.
Target Sample Size
450

Stratification factors

  • Donor type (MSD/MD vs MMD)
  • Age group (2-4 years vs >4 years)

Eligibility

Recruits 450 paediatric patients.

Pregnancy Exclusion
No pregnancy
Vulnerable Population
The study population includes minors (children and adolescents). Consent is required from parents/legal guardians; assent from the minor patient is obtained 'if necessary' via the Informed Consent Form. Age limits specified in eligibility: age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years. Multiple age-specific participant information sheets and informed consent forms are provided (documents for parents and for different minor age ranges), in country-specific language versions.

Inclusion criteria

  • {"criterion_text":"- All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:"}
  • {"criterion_text":"- Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years"}
  • {"criterion_text":"- Indication for allogeneic HSCT"}
  • {"criterion_text":"- Complete remission (CR) before SCT"}
  • {"criterion_text":"- Written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form”"}
  • {"criterion_text":"- No pregnancy"}
  • {"criterion_text":"- No secondary malignancy"}
  • {"criterion_text":"- No previous HSCT"}
  • {"criterion_text":"- HSCT is performed in a study participating centre"}

Exclusion criteria

  • {"criterion_text":"- Patients who do not fulfil the inclusion criteria"}
  • {"criterion_text":"- Non-Hodgkin Lymphoma"}
  • {"criterion_text":"- Whole protocol and/or its essential parts are refused either by the patient himself/herself or the respective legal guardian"}
  • {"criterion_text":"- No consent is given for saving and propagation of anonymous medical data for study reasons"}
  • {"criterion_text":"- Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion e.g.: malformation syndromes, cardiac malformations, metabolic disorders; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection"}
  • {"criterion_text":"- Karnofsky / Lansky score < 50%"}
  • {"criterion_text":"- Subjects unwilling or unable to comply with the study procedures"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Stratum 1: Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 2: Event Free Survival (EFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Stratum 1: EFS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 2: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 1 and 2: Cumulative Incidence of Relapse","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 1 and 2: Toxicity: acute and late","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Stratum 1 and 2: Secondary malignancies","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
450
Recruitment Window Months
206
Consent Approach
Written consent of the parents (legal guardian) is required and, if necessary, assent/consent from the minor patient via an Informed Consent Form. Age-specific information sheets and consent forms are prepared for multiple age ranges and for parents. Country-specific and language-specific ICFs and patient information sheets are provided (examples in Austria, Belgium – NL/FR/EN, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Slovakia, Spain, Sweden).

Geography

Total Number Of Sites
61
Total Number Of Participants
1108

Austria

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
14-10-2024
Number Of Sites
3
Number Of Participants
81

Sites

Site Name
St. Anna Kinderspital GmbH
Department Name
Hämatologische, Onkologische und Immunologische Abteilung, Stammzelltransplantationseinheit
Principal Investigator Name
Herbert Pichler
Principal Investigator Email
herbert.pichler@stanna.at
Contact Person Name
Herbert Pichler
Contact Person Email
herbert.pichler@stanna.at
Site Name
Medical University Of Graz
Department Name
Pädiatrische Hämato-Onkologie
Principal Investigator Name
Wolfgang Schwinger
Principal Investigator Email
wolfgang.schwinger@medunigraz.at
Contact Person Name
Wolfgang Schwinger
Site Name
Medizinische Universitaet Innsbruck
Department Name
Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Gabriele Kropshofer
Principal Investigator Email
gabriele.kropshofer@tirol-kliniken.at
Contact Person Name
Gabriele Kropshofer

Belgium

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
09-10-2024
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Paediatric haemato-oncology
Principal Investigator Name
Marie-Françoise Dresse
Principal Investigator Email
mf.dresse@chuliege.be
Contact Person Name
Marie-Françoise Dresse
Contact Person Email
mf.dresse@chuliege.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Paediatric haemato-oncology
Principal Investigator Name
Pauline Mazilier
Principal Investigator Email
pauline.mazilier@hubruxelles.be
Contact Person Name
Pauline Mazilier
Site Name
Universitair Ziekenhuis Gent
Department Name
Paediatric haemato-oncology
Principal Investigator Name
Vicky Bordon
Principal Investigator Email
victoria.bordon@uzgent.be
Contact Person Name
Vicky Bordon
Contact Person Email
victoria.bordon@uzgent.be
Site Name
UZ Leuven
Department Name
Paediatric haemato-oncology
Principal Investigator Name
Marleen Renard
Principal Investigator Email
marleen.renard@uzleuven.be
Contact Person Name
Marleen Renard
Contact Person Email
marleen.renard@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric haemato-oncology
Principal Investigator Name
Benedicte Brichard
Principal Investigator Email
benedicte.brichard@saintluc.uclouvain.be
Contact Person Name
Benedicte Brichard

Czechia

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
05-09-2025
Processing Time Days
329
Number Of Sites
1
Number Of Participants
56

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Petr Říha
Principal Investigator Email
petr.riha@fnmotol.cz
Contact Person Name
Petr Říha
Contact Person Email
petr.riha@fnmotol.cz

Denmark

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
10-10-2024
Number Of Sites
1
Number Of Participants
47

Sites

Site Name
Rigshospitalet
Department Name
Department of Paediatrics and Adolescent Medicine
Principal Investigator Name
Marianne Ifversen
Principal Investigator Email
marianne.ifversen@regionh.dk
Contact Person Name
Marianne Ifversen
Contact Person Email
marianne.ifversen@regionh.dk

France

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
491
Number Of Sites
13
Number Of Participants
203

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hématologie et oncologie pédiatrique
Principal Investigator Name
Michel Gérard
Principal Investigator Email
gmichel@ap-hm.fr
Contact Person Name
Michel Gérard
Contact Person Email
gmichel@ap-hm.fr
Site Name
Robert Debre University Hospital
Department Name
Hémato-immunologie pédiatrique
Principal Investigator Name
Jean-Hugues Dalle
Principal Investigator Email
jean-hugues.dalle@aphp.fr
Contact Person Name
Jean-Hugues Dalle
Contact Person Email
jean-hugues.dalle@aphp.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service d'hémato-Immuno-Oncologie pédiatrique
Principal Investigator Name
Pascale Schneider
Principal Investigator Email
pascale.schneider@chu-rouen.fr
Contact Person Name
Pascale Schneider
Contact Person Email
pascale.schneider@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de médecine de l'enfant et de l'adolescent - Unité d'hémato-oncologie
Principal Investigator Name
Virginie Gandemer
Principal Investigator Email
virginie.gandemer@chu-rennes.fr
Contact Person Name
Virginie Gandemer
Site Name
Hospices Civils De Lyon
Department Name
Institut d'hématologie et d'oncologie pédiatrique
Principal Investigator Name
Cecile Renard
Principal Investigator Email
cecile.renard@ihope.fr
Contact Person Name
Cecile Renard
Contact Person Email
cecile.renard@ihope.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service de Pédiatrie - Immuno-hémato-oncologie pédiatrique
Principal Investigator Name
Gaelle Stofleth
Principal Investigator Email
gsofleth@chu-grenoble.fr
Contact Person Name
Gaelle Stofleth
Contact Person Email
gsofleth@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie-Hématologie
Principal Investigator Name
Charlotte Jubert
Principal Investigator Email
charlotte.jubert@chu-bordeaux.fr
Contact Person Name
Charlotte Jubert
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Centre régional de cancérologie et de thérapie cellulaire pédiatrique
Principal Investigator Name
Justyna Kanold
Principal Investigator Email
j.kanold@chu-clermontferrand.fr
Contact Person Name
Justyna Kanold
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'onco hématologie pédiatrie
Principal Investigator Name
Fanny Rialland
Principal Investigator Email
fanny.rialland@chu-nantes.fr
Contact Person Name
Fanny Rialland
Contact Person Email
fanny.rialland@chu-nantes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d'hématologie et d'oncologie pédiatrique
Principal Investigator Name
Catherine Paillard
Principal Investigator Email
catherine.apillard@chru-strasbourg.fr
Contact Person Name
Catherine Paillard
Site Name
CHRU De Nancy
Department Name
Service d'oncologie pédiatrique
Principal Investigator Name
Cécile Pochon
Principal Investigator Email
c.pochon@chu-nancy.fr
Contact Person Name
Cécile Pochon
Contact Person Email
c.pochon@chu-nancy.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hématologie pédiatrique - Unité Greffe
Principal Investigator Name
Bruno Bénedicte
Principal Investigator Email
benedicte.bruno@chru-lille.fr
Contact Person Name
Bruno Bénedicte
Contact Person Email
benedicte.bruno@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Onco-hématologie pédiatrique
Principal Investigator Name
Anne-Charlotte Teyssier
Principal Investigator Email
ac-teyssier@chu-montpellier.fr
Contact Person Name
Anne-Charlotte Teyssier
Contact Person Email
ac-teyssier@chu-montpellier.fr

Germany

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
548
Number Of Sites
24
Number Of Participants
373

Sites

Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Klinik und Poliklinik für Pädiatrie I
Principal Investigator Name
Kinan Kafa
Principal Investigator Email
kinan.kafa@uk-halle.de
Contact Person Name
Kinan Kafa
Contact Person Email
kinan.kafa@uk-halle.de
Site Name
Universitaet Muenster
Department Name
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Claudia Rössig
Principal Investigator Email
rossig@ukmuenster.de
Contact Person Name
Claudia Rössig
Contact Person Email
rossig@ukmuenster.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Pädiatrische Onkologie, Hämatologie und Stammzelltransplantation
Principal Investigator Name
Anja Tröger
Principal Investigator Email
anja.troeger@ukr.de
Contact Person Name
Anja Tröger
Contact Person Email
anja.troeger@ukr.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik f. Kinder- u. Jugendmedizin, Kinderheilkunde III, Päd. Häm-Onkologie, Pneum. Kardiol. Rheum.
Principal Investigator Name
Stefan Schönberger
Principal Investigator Email
stefan.schoenberger@uk-essen.de
Contact Person Name
Stefan Schönberger
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Pädiatrische Hämatologie, Onkologie & Immundefekte
Principal Investigator Name
Christine Mauz-Körholz
Contact Person Name
Christine Mauz-Körholz
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Kinder-Onkologie, -Hämatologie und Klin. Immunologie, Bereich Päd. Stammzelltherapie
Principal Investigator Name
Roland Meisel
Principal Investigator Email
Meisel@med.uni-duesseldorf.de
Contact Person Name
Roland Meisel
Contact Person Email
Meisel@med.uni-duesseldorf.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Zentrum für Kinder- und Jugendmedizin, Abteilung Päd. Hämatologie / Onkologie
Principal Investigator Name
Dagmar Dilloo
Principal Investigator Email
dagmar.dilloo@ukbonn.de
Contact Person Name
Dagmar Dilloo
Contact Person Email
dagmar.dilloo@ukbonn.de
Site Name
Goethe University Frankfurt
Department Name
Klinik für Kinder- und Jugendmedizin, Schwerpunkt Stammzelltransplantation und Immunologie
Principal Investigator Name
Peter Bader
Principal Investigator Email
peter.bader@unimedizin-ffm.de
Contact Person Name
Peter Bader
Contact Person Email
peter.bader@unimedizin-ffm.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Pädiatrische Onkologie, Hämatologie, Stammzelltransplantation
Principal Investigator Name
Matthias Wölfl
Principal Investigator Email
Woelfl_M@ukw.de
Contact Person Name
Matthias Wölfl
Contact Person Email
Woelfl_M@ukw.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Brigitte Strahm
Principal Investigator Email
brigitte.strahm@uniklinik-freiburg.de
Contact Person Name
Brigitte Strahm
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Kinder- u. Jugendmedizin, Pädiatrische Immunologie, Rheumatologie u. Stammzelltransplan
Principal Investigator Name
Ansgar Schulz
Principal Investigator Email
ansgar.schulz@uniklinik-ulm.de
Contact Person Name
Ansgar Schulz
Contact Person Email
ansgar.schulz@uniklinik-ulm.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Kinder-u. Jugendmedizin Pädiatrische Hämatologie, Onkologie u. SZT
Principal Investigator Name
Udo Kontny
Principal Investigator Email
ukontny@ukaachen.de
Contact Person Name
Udo Kontny
Contact Person Email
ukontny@ukaachen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Kinder- und Jugendmedizin, Abteilung III, Onkologie, Hämatologie und Immunologie
Principal Investigator Name
Johann Greil
Principal Investigator Email
Johann.Greil@med.uni-heidelberg.de
Contact Person Name
Johann Greil
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum f. Geburtshilfe, Kinder- u. Jugendmedizin, Sektion f. Päd. Stammzelltransplant. u. Immunol.
Principal Investigator Name
Manon Queudeville
Principal Investigator Email
m.queudeville@uke.de
Contact Person Name
Manon Queudeville
Contact Person Email
m.queudeville@uke.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik für Kinder- und Jugendmedizin
Principal Investigator Name
Irene Teichert- von Lüttichau
Principal Investigator Email
irene.teichert-vonluettichau@mri.tum.de
Contact Person Name
Irene Teichert- von Lüttichau
Site Name
Universitaet Leipzig
Department Name
UKL, Department für Frauen- u. Kindermedizin, Abt. f. Pädiatrische Onkologie, Hämatologie u. Hämost.
Principal Investigator Name
Jörn-Sven Kühl
Principal Investigator Email
joern-sven.kuehl@medizin.uni-leipzig.de
Contact Person Name
Jörn-Sven Kühl
Site Name
Medizinische Hochschule Hannover
Department Name
Pädiatrische Hämatologie und Onkologie Medizinische Hochschule Hannover
Principal Investigator Name
Martin Sauer
Principal Investigator Email
Sauer.Martin@mh-hannover.de
Contact Person Name
Martin Sauer
Contact Person Email
Sauer.Martin@mh-hannover.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik für Kinder- und Jugendmedizin, Abteilung für päd. Hämatolgie und Onkologie
Principal Investigator Name
Holger Lode
Principal Investigator Email
holger.lode@med.uni-greifswald.de
Contact Person Name
Holger Lode
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Kinder- und Jugendklinik, Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Nora Naumann-Bartsch
Principal Investigator Email
nora.naumann@uk-erlangen.de
Contact Person Name
Nora Naumann-Bartsch
Contact Person Email
nora.naumann@uk-erlangen.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kinderonkologie und -rheumatologie
Principal Investigator Name
Gunnar Cario
Principal Investigator Email
gunnar.cario@uksh.de
Contact Person Name
Gunnar Cario
Contact Person Email
gunnar.cario@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Pädiatrie m. S. Hämatologie und Onkologie
Principal Investigator Name
Hedwig Deubzer
Principal Investigator Email
hedwig.deubzer@charite.de
Contact Person Name
Hedwig Deubzer
Contact Person Email
hedwig.deubzer@charite.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Kinder- und Jugendmedizin, Sektion Hämatologie / Onkologie / SZT
Principal Investigator Name
Bernd Gruhn
Principal Investigator Email
bernd.gruhn@med.uni-jena.de
Contact Person Name
Bernd Gruhn
Contact Person Email
bernd.gruhn@med.uni-jena.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Dr. von Haunersches Kinderspital, Abteilung Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Anna-Lisa Lanz
Principal Investigator Email
AnnaLisa.Lanz@med.uni-muenchen.de
Contact Person Name
Anna-Lisa Lanz
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Klinik für Kinder u. Jugendmedizin Abt. 1, Hämat., Onkologie, Gastroent., Nephrol., Rheumatologie
Principal Investigator Name
Peter Lang
Principal Investigator Email
peter.lang@med.uni-tuebingen.de
Contact Person Name
Peter Lang

Italy

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
25-11-2024
Number Of Sites
3
Number Of Participants
134

Sites

Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Clinica Pediatrica, Fondazione IRCCS San Gerardo dei Tintori Monza
Principal Investigator Name
Adriana Balduzzi
Principal Investigator Email
abalduzzi@fondazionembbm.it
Contact Person Name
Adriana Balduzzi
Contact Person Email
abalduzzi@fondazionembbm.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Marco Zecca
Principal Investigator Email
m.zecca@smatteo.pv.it
Contact Person Name
Marco Zecca
Contact Person Email
m.zecca@smatteo.pv.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
OncoEmatology, Cellular Therapy Gene Therapy and Hemopoietic Transplantation
Principal Investigator Name
Franco Locatelli
Principal Investigator Email
franco.locatelli@opbg.net
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net

Spain

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
10-10-2024
Number Of Sites
4
Number Of Participants
43

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Servicio de Oncología y Hematología Pediátricas
Principal Investigator Name
Pilar Palomo
Principal Investigator Email
pilarpalomo@gmail.com
Contact Person Name
Pilar Palomo
Contact Person Email
pilarpalomo@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Unidad de Hematología, Oncología y Trasplante Hematopoyético Servicio de Pediatría
Principal Investigator Name
Iván López Torija
Principal Investigator Email
ilopezt@santpau.cat
Contact Person Name
Iván López Torija
Contact Person Email
ilopezt@santpau.cat
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Jefe de Sección Servicio de Oncología y Hem. Ped. Vall d’Hebron Barcelona Hosp. Campus
Principal Investigator Name
Cristina Diaz de Heredia
Principal Investigator Email
cristina.diazdeheredia@vallhebron.cat
Contact Person Name
Cristina Diaz de Heredia
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Hospital de día de oncohematología infantil Segunda planta del hospital infantil
Principal Investigator Name
José Luis Fuster Soler
Principal Investigator Email
josel.fuster@carm.es
Contact Person Name
José Luis Fuster Soler
Contact Person Email
josel.fuster@carm.es

Sweden

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
11-10-2024
Number Of Sites
4
Number Of Participants
34

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of pediatric medicine
Principal Investigator Name
Dominik Turkiewicz
Principal Investigator Email
Dominik.Turkiewicz@skane.se
Contact Person Name
Dominik Turkiewicz
Contact Person Email
Dominik.Turkiewicz@skane.se
Site Name
Karolinska University Hospital
Department Name
Department of pediatrcis
Principal Investigator Name
Jacek Toporski
Principal Investigator Email
jacek.toporski@regionstockholm.se
Contact Person Name
Jacek Toporski
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Department Name
Children's Cancer Center
Principal Investigator Name
Cecilia Langenskiöld
Principal Investigator Email
cecilia.langenskiold@vgregion.se
Contact Person Name
Cecilia Langenskiöld
Site Name
Uppsala University Hospital
Department Name
Pediatric Oncology
Principal Investigator Name
Natalja Jackmann
Principal Investigator Email
natalja.jackmann@akademiska.se
Contact Person Name
Natalja Jackmann
Contact Person Email
natalja.jackmann@akademiska.se

Norway

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
10-10-2024
Number Of Sites
1
Number Of Participants
39

Sites

Site Name
Oslo University Hospital HF
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Jochen Buechner
Principal Investigator Email
jocbuc@ous-hf.no
Contact Person Name
Jochen Buechner
Contact Person Email
jocbuc@ous-hf.no

Slovakia

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
09-10-2024
Number Of Sites
1
Number Of Participants
37

Sites

Site Name
Narodny Ustav Detskych Chorob
Department Name
Department of Pediatric Hematology and Oncology
Principal Investigator Name
Peter Svec
Principal Investigator Email
peter.svec@nudch.eu
Contact Person Name
Peter Svec
Contact Person Email
peter.svec@nudch.eu

Netherlands

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
405
Number Of Sites
1
Number Of Participants
35

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Stem cell Transplantation and cellular therapy
Principal Investigator Name
Friso Calkoen
Principal Investigator Email
F.G.J.Calkoen-2@prinsesmaximacentrum.nl
Contact Person Name
Friso Calkoen

Sponsor

Primary sponsor

Full Name
St. Anna Childrens Cancer Research Institute GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Austria

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
FLUDARABINE PHOSPHATE
Active Substance
FLUDARABINE PHOSPHATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
30 mg/m2
Investigational Product Name
ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS
Active Substance
ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS
Modality
Other antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
15 mg/kg
Investigational Product Name
RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN
Active Substance
RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN
Modality
Other antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
2.5 mg/kg
Investigational Product Name
THIOTEPA
Active Substance
THIOTEPA
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
10 mg/kg
Investigational Product Name
FLUDARABINE PHOSPHATE (duplicate entry in product groups)
Active Substance
FLUDARABINE PHOSPHATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
30 mg/m2
Investigational Product Name
TREOSULFAN
Active Substance
TREOSULFAN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
14000 mg/m2
Investigational Product Name
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Active Substance
BLINATUMOMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
EU/1/15/1047/001
Orphan Designation
Yes
Maximum Dose
28 µg/m2
Investigational Product Name
BUSULFAN
Active Substance
BUSULFAN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
4.8 mg/kg
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
60 mg/kg
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
60 mg/kg
Combination Treatment
Yes

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