Clinical trial • Phase II • Oncology

BORTEZOMIB for Relapsed acute lymphoblastic leukemia (ALL)

Phase II trial of BORTEZOMIB for Relapsed acute lymphoblastic leukemia (ALL).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed acute lymphoblastic leukemia (ALL)
Trial Stage
Phase II
Drug Modality
Small molecule|Peptide/protein/enzyme
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
30-08-2024
First CTIS Authorization Date
30-09-2024

Trial design

Randomised, arm a: standard chemotherapy backbone (comparator products listed: oncaspar (pegaspargase) 750 u/ml powder for solution for injection/infusion; dexamethasone (dexamethasone phosphate accord 4 mg/ml solution for injection/infusion; max daily dose noted in product data 20 mg/m2); mitoxantrone (mitoxantrone 2 mg/ml concentrate for solution for infusion); methotrexate (methotrexate viatris 100 mg/ml solution injectable); vincristine (vincristine sulfate 1 mg/ml solution for injection or infusion)). arm b: same standard chemotherapy backbone plus bortezomib (velcade 3.5 mg powder for solution for injection; product dosing information: doseuom mg/m2, reported maxdailydoseamount 1.3 mg/m2, maxtotaldoseamount 5.2 mg/m2; route iv injection/infusion). (doses/schedules: product summaries provide dose units and maximum amounts but protocol‑specific schedule details not provided in the ctis metadata.)-controlled Phase II trial in France, Belgium, Czechia and others.

Randomised
Yes
Comparator
Arm A: standard chemotherapy backbone (comparator products listed: Oncaspar (pegaspargase) 750 U/ml powder for solution for injection/infusion; Dexamethasone (Dexamethasone phosphate Accord 4 mg/ml solution for injection/infusion; max daily dose noted in product data 20 mg/m2); Mitoxantrone (Mitoxantrone 2 mg/ml concentrate for solution for infusion); Methotrexate (METHOTREXATE VIATRIS 100 mg/ml solution injectable); Vincristine (Vincristine Sulfate 1 mg/ml solution for injection or infusion)). Arm B: same standard chemotherapy backbone plus Bortezomib (VELCADE 3.5 mg powder for solution for injection; product dosing information: doseUom mg/m2, reported maxDailyDoseAmount 1.3 mg/m2, maxTotalDoseAmount 5.2 mg/m2; route IV injection/infusion). (Doses/schedules: product summaries provide dose units and maximum amounts but protocol‑specific schedule details not provided in the CTIS metadata.)
Target Sample Size
222

Eligibility

Recruits 222 paediatric patients.

Pregnancy Exclusion
Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
Vulnerable Population
The trial enrols children (participants younger than 18). Written informed consent is required (inclusion criterion: "Written informed consent"). There are age‑specific subject information and consent/assent documents listed (SIS/ICF and assent forms for multiple age groups including 0-6, 7-11, 12-14, 12-17, 15-17, 16-17, and parent/guardian versions). Exclusion criteria explicitly note objection to participation by a minor who is able to object, and refusal of the protocol by the patient or legal guardian leads to exclusion. Consent is therefore obtained from parents/legal guardians with assent procedures for minors according to age ranges as documented in the ICF/SIS materials.

Inclusion criteria

  • {"criterion_text":"- Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL\n- Children less than 18 years of age at date of inclusion into the study.\n- Meeting HR criteria (any T BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)\n- Patient enrolled in a participating centre\n- Written informed consent\n- Start of treatment falling into the study period\n- No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL"}

Exclusion criteria

  • {"criterion_text":"- BCR-ABL/ t(9;22) positive ALL\n- No consent is given for saving and propagation of pseudonymized medical data for study reasons\n- 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\n- Subjects unwilling or unable to comply with the study procedures\n- Subjects who are legally detained in an official institute\n- Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)\n- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy\n- Breast feeding\n- Relapse post allogeneic stem-cell transplantation\n- Neuropathy > II°\n- The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian\n- Objection to the study participation by a minor patient, able to object\n- Any patient being dependent on the investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Randomized induction trial: Improvement of CR2 rates with standard chemotherapy + Bortezomib (Arm B) quantified by cytology compared with standard chemotherapy (Arm A)","definition_or_measurement_approach":"CR2 rates assessed/quantified by cytology comparing Arm B (standard chemotherapy + bortezomib) versus Arm A (standard chemotherapy)."}

Secondary endpoints

  • {"endpoint_text":"- Improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre HSCT, CR2 and MRD rates during consolidation, toxicity of randomized arms","definition_or_measurement_approach":"Endpoints include 3-year event-free survival (EFS) and overall survival (OS) rates; proportion of patients proceeding to haematopoietic stem cell transplant (HSCT); minimal residual disease (MRD) rates post-induction and pre-HSCT and during consolidation; prognostic relevance of pre-HSCT MRD; and toxicity comparison between randomized arms. MRD measured by local/central MRD assays as per protocol; survival rates measured at three years post-treatment; toxicity assessed by adverse event reporting (per protocol)."}

Recruitment

Planned Sample Size
222
Recruitment Window Months
125
Consent Approach
Written informed consent is required. Consent is obtained from parents/legal guardians for minors; age-specific information sheets and consent/assent forms are provided (documents available for parents/guardians and for children/ adolescents in multiple age bands including 0-6, 7-11, 12-14, 12-17, 15-17, 16-17, and adult versions). Language- and country-specific SIS/ICF documents are included in the submission package. Minors capable of objecting are explicitly protected ("Objection to the study participation by a minor patient, able to object").

Geography

Total Number Of Sites
111
Total Number Of Participants
222

France

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
02-10-2024
Processing Time Days
20
Number Of Sites
16
Number Of Participants
64

Sites

Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Onco-hématologie
Contact Person Name
Marlène PASQUET
Contact Person Email
pasquet.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Onco-hématologie
Contact Person Name
Claire PLUCHART
Contact Person Email
cpluchart@chu-reims.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Onco-hématologie
Contact Person Name
Dalila ADJAOUD
Contact Person Email
DAdjaoud@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Onco-hématologie
Contact Person Name
Brigitte NELKEN
Contact Person Email
Brigitte.NELKEN@CHRU-LILLE.FR
Site Name
CHU Besancon
Department Name
Onco-hématologie
Contact Person Name
Pauline SIMON
Contact Person Email
p1simon@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Onco-hématologie
Contact Person Name
Pierre-Simon ROHRLICH
Contact Person Email
rohrlich.ps@chu-nice.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Onco-hématologie
Contact Person Name
Pascale SCHNEIDER
Contact Person Email
pascale.schneider@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Onco-hématologie
Contact Person Name
Frédéric MILLOT
Contact Person Email
f.millot@chu-poitiers.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Onco-hématologie
Contact Person Name
Gérard MICHEL
Contact Person Email
Gerard.MICHEL@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Onco-hématologie
Contact Person Name
Arnaud PETIT
Contact Person Email
arnaud.petit@trs.aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Onco-hématologie
Contact Person Name
Fanny RIALLAND
Contact Person Email
fanny.rialland@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Onco-hématologie
Contact Person Name
Virginie GANDEMER
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Onco-hématologie
Contact Person Name
Charlotte JUBERT
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Onco-hématologie
Contact Person Name
Catherine PAILLARD
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Onco-hématologie
Contact Person Name
Marion STRULLU
Contact Person Email
marion.strullu@aphp.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Onco-hématologie
Contact Person Name
Damien BODET
Contact Person Email
bodet-d@chu-caen.fr

Belgium

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
18
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
CHC MontLegia
Department Name
Paediatric Haematology and oncology
Contact Person Name
Pierre Philippet
Contact Person Email
pierre.philippet@chc.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Paediatric Haematology and oncology
Contact Person Name
Maelle de Ville De Goyet
Contact Person Email
maelle.deville@uclouvain.be
Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Paediatric Haematology and oncology
Contact Person Name
Laurence Dedeken
Site Name
UZ Leuven
Department Name
Paediatric Haematology and oncology
Contact Person Name
Heidi Segers
Contact Person Email
heidi.segers@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Paediatric Haematology and oncology
Contact Person Name
Jaques Van Heerden
Contact Person Email
jaques.vanheerden@uza.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Paediatric Haematology and oncology
Contact Person Name
Marie-Françoise Dresse
Contact Person Email
MF.Dresse@chuliege.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Paediatric Haematology and oncology
Contact Person Name
Barbara De Moerloose
Contact Person Email
barbara.demoerloose@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
01-10-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika dětské hematologie a onkologie
Contact Person Name
Lucie Šrámková
Contact Person Email
lucie.sramkova@fnmotol.cz

Finland

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
04-10-2024
Processing Time Days
22
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
HUS-Yhtymae
Department Name
pediatric and adolescent hematology and oncology
Contact Person Name
Mervi Taskinen
Contact Person Email
mervi.taskinen@hus.fi
Site Name
Pirkanmaan hyvinvointialue
Department Name
pediatric hematology and oncology
Contact Person Name
Olli Lohi
Contact Person Email
olli.lohi@pirha.fi
Site Name
Varsinais-Suomen hyvinvointialue
Department Name
pediatric and adolescent hematology and oncology
Contact Person Name
Päivi Lähteenmäki
Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
pediatric hematology and oncology
Contact Person Name
Hanna Juntti
Contact Person Email
hanna.juntti@pohde.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
pediatric hematology and oncology
Contact Person Name
Jouni Pesola

Italy

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
67
Number Of Sites
13
Number Of Participants
36

Sites

Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Delia Russo
Contact Person Email
drdeliarusso@gmail.com
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Area Studi Clinici Oncoematologici e Terapie Cellulari
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Simona Gobbi
Site Name
Azienda Ospediera Santobono Pausilipon
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Rosanna Parasole
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Fraia Melchionda
Contact Person Email
fraia.melchionda@aosp.bo.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Maurizio Caniglia
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Simone Cesaro
Contact Person Email
simone.cesaro@aovr.veneto.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Angelica Barone
Contact Person Email
abarone@ao.pr.it
Site Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Marco Rabusin
Contact Person Email
marco.rabusin@burlo.trieste.it
Site Name
ARNAS G. Brotzu
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Rosa Maria Mura
Contact Person Email
rosamaria.mura@aob.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Onco-ematologia Pediatrica
Contact Person Name
Concetta Micalizzi
Contact Person Email
concettamicalizzi@gaslini.org
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Oncoematologia-Pediatrica
Contact Person Name
Carmelo Rizzari

Spain

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
18
Number Of Sites
16
Number Of Participants
19

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Contact Person Name
Vanesa Pérez
Contact Person Email
vpereza@salud.madrid.org
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Berta Gonzalez
Contact Person Email
bertagonzalezm@gmail.com
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Medical Oncology
Contact Person Name
Susana Rives
Contact Person Email
susana.rives@sjd.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Agueda Molinos
Contact Person Email
aguedamolinos@hotmail.com
Site Name
Hospital Universitario De Cruces
Department Name
Medical Oncology
Contact Person Name
Rosa Maria Adan
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Medical Oncology
Contact Person Name
Alexandra Regueiro Garcia
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Medical Oncology
Contact Person Name
José Luis Fuster
Contact Person Email
josel.fuster@carm.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Carolina Fuentes
Contact Person Email
fuentes_car@gva.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Marina Garcia
Contact Person Email
mgmorin@salud.madrid.org
Site Name
University Hospital Son Espases
Department Name
Medical Oncology
Contact Person Name
Samuel Navarro
Contact Person Email
samuel.navarro@ssib.es
Site Name
Hospital Universitario Miguel Servet
Department Name
Medical Oncology
Contact Person Name
Yurena Aguilar
Contact Person Email
yurenaaguilar@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Pablo Velsaco
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology
Contact Person Name
Ana Fernandez-Tejeiro
Contact Person Email
anateijeiro@hotmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology
Contact Person Name
Ana Isabel Rodríguez
Contact Person Email
anarjimenez@me.com
Site Name
Fundacion De La Comunitat Valenciana Para La Gestion Del Instituto De Investigacion Sanitaria Y Biomedica De Alicante
Department Name
Medical Oncology
Contact Person Name
Maria Tasso
Contact Person Email
tasso_mar@gva.es
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Medical Oncology
Contact Person Name
Alvaro Lassaletta
Contact Person Email
lassaalvaro@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
62
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Uniwersytecki Szpital Dzieciecy W Lublinie
Department Name
Klinika Hematologii, Onkologii i Transplantologii Dziecięcej
Contact Person Name
Agnieszka Zaucha-Prażmo
Contact Person Email
a.prazmo@umlub.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej
Contact Person Name
Monika Mielcarek-Siedziuk
Contact Person Email
mmielcarek@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
Klinika Pediatrii, Onkologii, Hematologii i Diabetologii
Contact Person Name
Wojciech Młynarski

Austria

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
25
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Uniklinik für Kinder- u. Jugendheilkunde - Onkologie
Contact Person Name
Barbara Winkler
Site Name
Medical University Of Graz
Department Name
Uniklinik für Kinder- u. Jugendheilkunde - Klinische Abteilung für pädiatrische Hämato-Onkologie
Contact Person Name
Martin Benesch
Site Name
St. Anna Kinderspital GmbH
Department Name
Hämatologische, Onkologische und Immunologische Abteilung
Contact Person Name
Andishe Attarbaschi
Contact Person Email
andishe.attarbaschi@stanna.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Kinder- und Jugendheilkunde - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Contact Person Name
Roman Crazzolara
Contact Person Email
mui-oversight@i-med.ac.at

Netherlands

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
18
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Hemato-oncology
Contact Person Name
J. Stutterheim

Portugal

Earliest CTIS Part Ii Submission Date
06-02-2025
Latest Decision Or Authorization Date
13-02-2025
Processing Time Days
7
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Hospital Pediátrico de Coimbra - Serviço de Oncologia Pediátrica
Contact Person Name
Manuel Brito
Contact Person Email
mjbrito@chuc.min-saude.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Pediatria
Contact Person Name
Marta Almeida
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Serviço de Pediatria
Contact Person Name
Joaquin Ernesto (Ximo) Duarte
Contact Person Email
jduarte@ipolisboa.min-saude.pt

Germany

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
07-10-2024
Processing Time Days
25
Number Of Sites
40
Number Of Participants
50

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Michael Schündeln
Contact Person Email
michael.schuendeln@uk-essen.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Norbert Jorch
Contact Person Email
Norbert.Jorch@evkb.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
PD Dr. Claudia Blattmann
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Stefan Balzer
Contact Person Email
BalzerSt@kliniken-koeln.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Norbert Graf
Contact Person Email
graf@uks.eu
Site Name
Carl-Thiem-Klinikum Cottbus gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Georg Schwabe
Contact Person Email
g.schwabe@ctk.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Peter Lang
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Gabriele Escherich
Contact Person Email
escherich@uke.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Gunnar Cario
Contact Person Email
Gunnar.Cario@uksh.de
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Andreas Beilken
Contact Person Email
a.beilken@skbs.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Holger Lode
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Vera Binder
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Alfred Leipold
Site Name
Klinikum Dortmund gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Dominik Schneider
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Stefan Fröhling
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Matthias Wölfl
Contact Person Email
woelfl_m@ukw.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Dagmar Dilloo
Contact Person Email
kho.sekretariat@ukbonn.de
Site Name
Medical Center - University Of Freiburg
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Christian Flotho
Site Name
HELIOS Kliniken GmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Patrick Hundsdörfer
Site Name
Vestische Kinder Und Jugendklinik Datteln
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Thomas Wiesel
Site Name
Asklepios Klinik Sankt Augustin GmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Martin Irnich
Contact Person Email
m.irnich@asklepios.com
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Markus Metzler
Contact Person Email
markus.metzler@uk-erlangen.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Michael Frühwald
Site Name
Muenchen Klinik gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Angela Wawer
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Konrad Bochennek
Contact Person Email
Konrad.bochennek@kgu.de
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Antje Redlich
Contact Person Email
Antje.Redlich@med.ovgu.de
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Claudia Rössig
Contact Person Email
rossig@uni-muenster.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Lars Fischer
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Toralf Bernig@uk-halle.de
Contact Person Email
toralf.bernig@uk-halle.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Bernd Gruhn
Contact Person Email
bernd.gruhn@med.uni-jena.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Selim Corbacioglu
Contact Person Email
selim.corbacioglu@ukr.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Udo Kontny
Contact Person Email
ukontny@ukaachende
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Aram Prokop
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Dieter Koerholz
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Arndt Borkhardt
Site Name
Klinikum Kassel GmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Michaela Nathrath
Site Name
University Hospital Cologne AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Thorsten Simon
Contact Person Email
Thorsten.Simon@uk-koeln.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Christof Kramm
Site Name
Gemeinschaftsklinikum Mittelrhein gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Ümmügül Behr
Contact Person Email
uemmueguel.behr@gk.de
Site Name
Universitaet Rostock
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Carl-Friedrich Classen
Site Name
Gemeinschaftskrankenhaus Herdecke gGmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Alfred Laengler
Site Name
Klinikum Oldenburg AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Hermann Müller
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Bjoern Soenke Lange
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Christian Reinmann
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Jörg Faber
Contact Person Email
faber@uni-mainz.de
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Axel Sauerbrey
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Paedriatrics, Department of Oncology and Hematology
Contact Person Name
Arend von Stackelberg
Contact Person Email
arend.stackelberg@charite.de

Sponsor

Primary sponsor

Full Name
Charite Universitaetsmedizin Berlin KöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
VELCADE 3.5 mg powder for solution for injection
Active Substance
BORTEZOMIB
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV injection/infusion
Authorisation Status
Authorised (EU/1/04/274/001)
Starting Dose
1.3 mg/m2
Maximum Dose
5.2 mg/m2 (total, as reported)
Investigational Product Name
Oncaspar 750 U/ml powder for solution for injection/infusion
Active Substance
PEGASPARGASE
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (EU/1/15/1070/002)
Starting Dose
1000 IU (product maxDailyDoseAmount reported as 1000 IU)
Maximum Dose
4000 IU (total, as reported)
Investigational Product Name
Dexamethasone phosphate Accord 4 mg/ml injeksjons-/infusjonsvæske, oppløsning
Active Substance
DEXAMETHASONE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised (22-14690)
Starting Dose
20 mg/m2 (reported maxDailyDoseAmount)
Maximum Dose
380 mg/m2 (reported maxTotalDoseAmount)
Investigational Product Name
Mitoxantrone 2 mg/ml concentrate for solution for infusion
Active Substance
MITOXANTRONE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (PL 20075/0412)
Starting Dose
10 mg/m2 (reported maxDailyDoseAmount)
Maximum Dose
20 mg/m2 (reported maxTotalDoseAmount)
Investigational Product Name
METHOTREXATE VIATRIS 100 mg/ml, solution injectable
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (34009 564 243 0 6)
Starting Dose
1000 mg/m2 (reported maxDailyDoseAmount)
Maximum Dose
2000 mg/m2 (reported maxTotalDoseAmount)
Investigational Product Name
Vincristine Sulfate 1 mg/ml Solution for Injection or Infusion
Active Substance
VINCRISTINE SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (MA505/09402)
Starting Dose
1.5 mg/m2 (reported maxDailyDoseAmount)
Maximum Dose
9 mg/m2 (reported maxTotalDoseAmount)
Combination Treatment
Yes

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