Clinical trial • Phase III • Oncology|Haematology

Inotuzumab ozogamicin for Relapsed precursor B-cell acute lymphoblastic leukemia (relapsed B-cell precursor ALL)

Phase III trial of Inotuzumab ozogamicin for Relapsed precursor B-cell acute lymphoblastic leukemia (relapsed B-cell precursor ALL).

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Relapsed precursor B-cell acute lymphoblastic leukemia (relapsed B-cell precursor ALL)
Trial Stage
Phase III
Drug Modality
ADC|Bispecific antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
22-08-2025
First CTIS Authorization Date
09-12-2025

Trial design

Randomised, standard of care/chemotherapy comparator (allr3-mitox and other soc regimens) comprising agents listed as comparators in the protocol: thioguanine; prednisolone (solu-dacortin); vindesine (eldisine); cyclophosphamide; pegaspargase (oncaspar); ifosfamide; etoposide; cytarabine; vincristine; methotrexate; daunorubicin; mitoxantrone; idarubicin (zavedos); mercaptopurine; methotrexate formulations; dexamethasone.-controlled Phase III trial in Germany, Finland, Spain and others.

Randomised
Yes
Comparator
Standard of care/chemotherapy comparator (ALLR3-Mitox and other SOC regimens) comprising agents listed as comparators in the protocol: Thioguanine; Prednisolone (Solu-Dacortin); Vindesine (ELDISINE); Cyclophosphamide; Pegaspargase (Oncaspar); Ifosfamide; Etoposide; Cytarabine; Vincristine; Methotrexate; Daunorubicin; Mitoxantrone; Idarubicin (Zavedos); Mercaptopurine; Methotrexate formulations; Dexamethasone.
Biomarker Stratified
True - Biomarkers: CD22 (>80% vs <80% by flow cytometry); CD19 (>10% vs ≤10%)
Target Sample Size
765

Stratification factors

  • Standard-risk (SR) vs High-risk (HR) assignment
  • CD22 expression on leukemic blasts (>80% vs <80%)
  • CD19 positivity at relapse (>10% vs ≤10%)
  • Intolerance to PEG-asparaginase / Erwinase (stratification to InO arm)
  • MRD response categories (good vs poor)

Eligibility

Recruits 765 paediatric patients.

Pregnancy Exclusion
Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment
Vulnerable Population
The study includes minors (patients ≥1 year and <18 years at primary ALL diagnosis and <21 years at inclusion). Vulnerable population flag is set. Written informed consent is required from parents/legal guardians; age-appropriate information sheets and consent/assent forms are provided (e.g., forms for parents/guardians, participants 6-11 years, 12-17 years, mature minors). The protocol excludes participation where a minor objects. Country/site-specific participant/guardian information and consent documents are prepared.

Inclusion criteria

  • {"criterion_text":"- All study questions: Confirmed diagnosis of 1st relapsed B-cell precursor ALL\n- All study questions: Start of treatment falling into the study period\n- Meeting SR criteria: No previous history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)\n- All study questions: No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL\n- Specific for SR induction randomization: Meeting SR criteria\n- Meeting SR criteria: BM involvement (≥ 1% leukemic blasts)\n- Meeting SR criteria: CD22 positive ALL (>80% confirmed by flow-cytometry)\n- Specific for SR MRD poor response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis\n- Specific for SR MRD poor response consolidation: M1/CR2 and MRD ≥ 10-4 after induction\n- Specific for SR MRD poor response consolidation: CD19 positive ALL at relapse (>10%)\n- Specific for SR MRD good response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis\n- Specific for HR consolidation arm: M1/CR2 after induction therapy\n- Specific for SR MRD good response consolidation: M1/CR2 and MRD < 10-4 after induction\n- Specific for SR MRD good response consolidation: CD19 positive ALL at relapse (>10%)\n- Specific for HR consolidation arm: Meeting HR or VHR (in case of no possibility to be treated with CAR T cells) criteria\n- All study questions: Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study\n- Specific for HR consolidation arm: CD19 positive ALL at relapse (>10%)\n- Specific for IEM arm: Histology or cytology proven extramedullary relapse\n- Specific for IEM arm: No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD <1%\n- Specific for IEM arm: CD19 positive ALL at relapse (>10%)\n- All study questions: Patient enrolled in a participating center\n- All study questions: Written informed consent (IC)"}

Exclusion criteria

  • {"criterion_text":"- Known hypersensitivity to the active substances or excipients of the IMP’s or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase\n- Left ventricular ejection fraction (LVEF) < 50% or fractional shortening < 25%, and/or current or prior treatment for cardiomyopathy and/or history of clinically significant arrhythmias\n- Severe concomitant disease that, according to the treating physician, 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 in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment\n- Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy\n- Women not willing to refrain from Bbreast feeding until 12 months after end of anti-leukemic therapy\n- Relapse post allogeneic HSCT\n- Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator’s clinical judgment would-\tcompromise the patient’s ability to safely receive or tolerate inotuzumab ozogamicin and/or blinatumomab -\tsignificantly interfere with assessment of treatment efficacy or safety -\tmake it unlikely that the patient would derive clinical benefit from protocol therapy -\tpreclude adherence to study procedures or follow-up requirements\n- Specific for SR induction randomization: Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm\n- Relapse post chimeric antigen receptor T-cell (CAR-T) therapy\n- Specific for SR induction randomization: Patients with insufficient expression of CD22 (< 80%) on leukemic blasts, they are assigned to the control chemotherapy arm\n- Specific for blinatumomab treatment: Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)\n- Specific for blinatumomab treatment: Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment\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\n- Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)\n- Specific for SR induction randomization: Prior confirmed severe (grade 3 or 4) or ongoing VOD/SOS\n- Specific for SR induction randomization: Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic/therapeutic measures\n- Specific for SR induction randomization: ALT > 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and/or bilirubin > 1.5 x ULN\n- No consent is given for saving and propagation of pseudonymized medical data for study reasons"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- SR induction: Event-free survival (EFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR-MRD good response consolidation: DFS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- HR with CR2 consolidation: DFS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- IEM: EFS","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- SR induction: MRD negativity rate after induction","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR induction: Proportion of patients requiring allo-HSCT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR induction: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR induction: Toxicity (assessed by CTCAE grades and SAE reports)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR induction: Rate of patients with CD19 positive cells after SCB1 prior to Blinatumomab","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR-MRD good response consolidation: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SR-MRD good response consolidation: Toxicity (quantified by CTCAE grades and SAE reports)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- HR with CR2 consolidation: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- HR with CR2 consolidation: MRD negativity rates before allo-HSCT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- HR with CR2 consolidation: allo-HSCT rates","definition_or_measurement_approach":""}
  • {"endpoint_text":"- IEM: EFS by MRD at relapse diagnosis (cut-off 10-4)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- IEM: OS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- IEM: DFS by MRD after induction (cut-off 10-4) in patients with BM MRD > 10e-4 at relapse","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Serum pharmacokinetic parameters of InO (Cmax and Ctrough)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
765
Recruitment Window Months
84
Consent Approach
Written informed consent is required. Consent is provided by parents/legal guardians for minors; age-appropriate assent and information sheets are provided (documents for parents/guardians, participants 6-11 years, 12-17 years, mature minors). The trial includes country/site-specific informed consent and information materials (documents available in multiple languages and country-specific versions). Minors capable of objecting will have their objection respected (exclusion criterion).

Geography

Total Number Of Sites
88
Total Number Of Participants
765

Germany

Earliest CTIS Part Ii Submission Date
08-11-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
37
Number Of Sites
1
Number Of Participants
250

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Paediatric Oncology and Hematology
Principal Investigator Name
Arend Stackelberg
Principal Investigator Email
arend.stackelberg@charite.de
Contact Person Name
Arend Stackelberg
Contact Person Email
arend.stackelberg@charite.de

Finland

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
29
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Turku University Hospital
Department Name
Paediatric and Adolescent Ward
Principal Investigator Name
Laura Korhonen
Principal Investigator Email
laura.korhonen@varha.fi
Contact Person Name
Laura Korhonen
Contact Person Email
laura.korhonen@varha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Pediatrics
Principal Investigator Name
Kaisa Vepsäläinen
Principal Investigator Email
kaisa.vepsalainen@pshyvinvointialue.fi
Contact Person Name
Kaisa Vepsäläinen
Site Name
Tampere University Hospital
Department Name
Department of Pediatrics
Principal Investigator Name
Olli Lohi
Principal Investigator Email
olli.lohi@pirha.fi
Contact Person Name
Olli Lohi
Contact Person Email
olli.lohi@pirha.fi
Site Name
HUS-Yhtymae
Department Name
Children and Adolescents
Principal Investigator Name
Samppa Ryhänen
Principal Investigator Email
samppa.ryhanen@hus.fi
Contact Person Name
Samppa Ryhänen
Contact Person Email
samppa.ryhanen@hus.fi
Site Name
Oulu University Hospital
Department Name
Department of Pediatrics
Principal Investigator Name
Riitta Niinimäki
Principal Investigator Email
riitta.niinimaki@pohde.fi
Contact Person Name
Riitta Niinimäki
Contact Person Email
riitta.niinimaki@pohde.fi

Spain

Earliest CTIS Part Ii Submission Date
17-10-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
55
Number Of Sites
15
Number Of Participants
200

Sites

Site Name
Hospital Universitario De Cruces
Department Name
Pediatric oncology
Principal Investigator Name
Rosa María Adán Pedroso
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Rosa María Adán Pedroso
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric oncohematology
Principal Investigator Name
Carolina Fuentes Socorro
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Carolina Fuentes Socorro
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Pediatric oncohematology
Principal Investigator Name
Blanca Herrero Velasco
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Blanca Herrero Velasco
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Pediatric oncohematology
Principal Investigator Name
Yurena Aguilar de la Red
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Yurena Aguilar de la Red
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Hematology
Principal Investigator Name
Ana Isabel Rodríguez Jiménez
Principal Investigator Email
estudios.clinicos@ibima.eu
Contact Person Name
Ana Isabel Rodríguez Jiménez
Contact Person Email
estudios.clinicos@ibima.eu
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Oncohematology
Principal Investigator Name
José Luís Dapena Díaz
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
José Luís Dapena Díaz
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pediatric oncohematology
Principal Investigator Name
Pablo Velasco Puyo
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Pablo Velasco Puyo
Contact Person Email
aaaaa@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Alexandra Regueiro García
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Alexandra Regueiro García
Contact Person Email
aaaaa@gmail.com
Site Name
University Hospital Son Espases
Department Name
Pediatric oncohematology
Principal Investigator Name
Samuel Navarro Noguera
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Samuel Navarro Noguera
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Pediatric oncohematology
Principal Investigator Name
Berta González Martínez
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Berta González Martínez
Contact Person Email
aaaaa@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Pediatric oncology
Principal Investigator Name
José Luís Fuster Soler
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
José Luís Fuster Soler
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Pediatric oncology
Principal Investigator Name
Laura Ureña Horno
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Laura Ureña Horno
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Pediatric oncohematology
Principal Investigator Name
Vanesa Pérez Alonso
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Vanesa Pérez Alonso
Contact Person Email
aaaaa@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Agueda Molinos Quintana
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Agueda Molinos Quintana
Contact Person Email
aaaaa@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Pediatric oncohematology
Principal Investigator Name
Marina García Morin
Principal Investigator Email
aaaaa@gmail.com
Contact Person Name
Marina García Morin
Contact Person Email
aaaaa@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
34
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika dětské hematologie a onkologie
Principal Investigator Name
Lucie Šrámková
Principal Investigator Email
lucie.sramkova@fnmotol.cz
Contact Person Name
Lucie Šrámková
Contact Person Email
lucie.sramkova@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Dětská klinika
Principal Investigator Name
Zbyněk Novák
Principal Investigator Email
Zbynek.Novak@fnol.cz
Contact Person Name
Zbyněk Novák
Contact Person Email
Zbynek.Novak@fnol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika dětské onkologie
Principal Investigator Name
Andrea Bobeková
Principal Investigator Email
bobekova.andrea@fnbrno.cz
Contact Person Name
Andrea Bobeková
Contact Person Email
bobekova.andrea@fnbrno.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Dětská klinika
Principal Investigator Name
Tomáš Votava
Principal Investigator Email
votavat@fnplzen.cz
Contact Person Name
Tomáš Votava
Contact Person Email
votavat@fnplzen.cz

France

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
68
Number Of Sites
26
Number Of Participants
150

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hématologie pédiatrique
Principal Investigator Name
Catherine PAILLARD
Principal Investigator Email
catherine.paillard@chru-strasbourg.fr
Contact Person Name
Catherine PAILLARD
Site Name
Hospices Civils De Lyon
Department Name
Hématologie pédiatrique
Principal Investigator Name
Carine HALFON-DOMENECH
Principal Investigator Email
carine.halfondomenech@ihope.fr
Contact Person Name
Carine HALFON-DOMENECH
Contact Person Email
carine.halfondomenech@ihope.fr
Site Name
CHRU Nancy - Hopitaux Brabois
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Cécile POCHON
Principal Investigator Email
c.pochon@chru-nancy.fr
Contact Person Name
Cécile POCHON
Contact Person Email
c.pochon@chru-nancy.fr
Site Name
CHU de Tours - Hôpital Clocheville
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Julien LEJEUNE
Principal Investigator Email
j.lejeune@chu-tours.fr
Contact Person Name
Julien LEJEUNE
Contact Person Email
j.lejeune@chu-tours.fr
Site Name
CHU Nantes - HME-Department onco-hematology pédiatric
Department Name
Hématologie pédiatrique
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
Hopital Saint Louis
Department Name
Hématologie pédiatrique
Principal Investigator Name
Nicolas BOISSEL
Principal Investigator Email
nicolas.boissel@aphp.fr
Contact Person Name
Nicolas BOISSEL
Contact Person Email
nicolas.boissel@aphp.fr
Site Name
AP-HM- Hôpital de La Timone
Department Name
Hématologie pédiatrique
Principal Investigator Name
Paul SAULTIER
Principal Investigator Email
Paul.saultier@ap-hm.fr
Contact Person Name
Paul SAULTIER
Contact Person Email
Paul.saultier@ap-hm.fr
Site Name
Hôpital Jeanne de Flandre
Department Name
Onco-hématologie
Principal Investigator Name
Brigitte NELKEN
Principal Investigator Email
brigitte.nelken@chru-lille.fr
Contact Person Name
Brigitte NELKEN
Contact Person Email
brigitte.nelken@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Stéphane DUCASSOU
Principal Investigator Email
stephane.ducassou@chu-bordeaux.fr
Contact Person Name
Stéphane DUCASSOU
Site Name
CHU Dijon Bourgogne Hôpital François Mitterand
Department Name
Hématologie pédiatrique
Principal Investigator Name
Florent NEUMANN
Principal Investigator Email
Florent.neumann@chu-dijon.fr
Contact Person Name
Florent NEUMANN
Contact Person Email
Florent.neumann@chu-dijon.fr
Site Name
CHU de Montpellier
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Stéphanie HAOUY
Principal Investigator Email
s-haouy@chu-montpellier.fr
Contact Person Name
Stéphanie HAOUY
Contact Person Email
s-haouy@chu-montpellier.fr
Site Name
CHU Amiens - Groupe Hospitalier Sud
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Antoine GOURMEL
Principal Investigator Email
gourmel.antoine@chu-amiens.fr
Contact Person Name
Antoine GOURMEL
Contact Person Email
gourmel.antoine@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Anamaria STETCO
Principal Investigator Email
anamaria-ioana.stetco@chu-poitiers.fr
Contact Person Name
Anamaria STETCO
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Virginie GANDEMER
Principal Investigator Email
Virginie.gandemer@chu-rennes.fr
Contact Person Name
Virginie GANDEMER
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Onco-hématologie
Principal Investigator Name
Pierre-Simon ROHRLICH
Principal Investigator Email
rohrlich.ps@chu-nice.fr
Contact Person Name
Pierre-Simon ROHRLICH
Contact Person Email
rohrlich.ps@chu-nice.fr
Site Name
CHU CLERMONT FERRAND - Hôpital Estaing
Department Name
Hématologie pédiatrique
Principal Investigator Name
Justyna KANOLD
Principal Investigator Email
jkanold@chu-clermontferrand.fr
Contact Person Name
Justyna KANOLD
Contact Person Email
jkanold@chu-clermontferrand.fr
Site Name
CHU Limoges
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Christophe PIGUET
Principal Investigator Email
ean-francois.faucher@unilim.fr
Contact Person Name
Christophe PIGUET
Contact Person Email
ean-francois.faucher@unilim.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Nimrad BUCHBINDER
Principal Investigator Email
Nimrid.buchbinder@chu-rouen.fr
Contact Person Name
Nimrad BUCHBINDER
Contact Person Email
Nimrid.buchbinder@chu-rouen.fr
Site Name
CHU Grenoble
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Dalila ADJAOUD
Principal Investigator Email
dadjaoud@chu-grenoble.fr
Contact Person Name
Dalila ADJAOUD
Contact Person Email
dadjaoud@chu-grenoble.fr
Site Name
CHU Saint Etienne Hôpital Nord
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Sandrine THOUVENIN-DOULET
Principal Investigator Email
sandrine.thouvenin@chu-st-etienne.fr
Contact Person Name
Sandrine THOUVENIN-DOULET
Site Name
CHU Réunion
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Yves REGUERRE
Principal Investigator Email
yves.reguerre@chu-reunion.fr
Contact Person Name
Yves REGUERRE
Contact Person Email
yves.reguerre@chu-reunion.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Arnaud PETIT
Principal Investigator Email
arnaud.petit@aphp.fr
Contact Person Name
Arnaud PETIT
Contact Person Email
arnaud.petit@aphp.fr
Site Name
CHU Angers
Department Name
Onco-Hématologie pédiatrique
Principal Investigator Name
Isabelle PELLIER
Principal Investigator Email
ispellier@chu-angers.fr
Contact Person Name
Isabelle PELLIER
Contact Person Email
ispellier@chu-angers.fr
Site Name
CHU Besancon
Department Name
Hématologie pédiatrique
Principal Investigator Name
Pauline SIMON
Principal Investigator Email
p1simon@chu-besancon.fr
Contact Person Name
Pauline SIMON
Contact Person Email
p1simon@chu-besancon.fr

Sweden

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
12-12-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Region Oestergoetland (Universitetssjukhuset Linköping)
Department Name
Universitetssjukhuset Linköping Barn- och ungdomskliniken BOND
Principal Investigator Name
Hartmut Vogt
Principal Investigator Email
Hartmut.Vogt@regionostergotland.se
Contact Person Name
Hartmut Vogt
Site Name
Region Vaesterbotten (Umea)
Department Name
Norrlands Universitetssjukhus Barn- och Ungdomskliniken Barnavdelning 3
Principal Investigator Name
Ulrika Norén Nyström
Principal Investigator Email
ulrika.noren-nystrom@umu.se
Contact Person Name
Ulrika Norén Nyström
Contact Person Email
ulrika.noren-nystrom@umu.se
Site Name
Region Skane Skanes Universitetssjukhus (Lund)
Department Name
Barncancercentrum Avd 64, Skånes Universitetssjukhus Lund
Principal Investigator Name
Ladislav Król
Principal Investigator Email
ladislav.krol@skane.se
Contact Person Name
Ladislav Król
Contact Person Email
ladislav.krol@skane.se
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital (Gothenburg)
Department Name
Sahlgrenska Universitetssjukhuset, Barncancercentrum
Principal Investigator Name
Monika Renkielska
Principal Investigator Email
monika.renkielska@vgregion.se
Contact Person Name
Monika Renkielska
Contact Person Email
monika.renkielska@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Pediatric Oncology Unit Karolinska University Hospital
Principal Investigator Name
Petter Svenberg
Principal Investigator Email
petter.svenberg@regionstockholm.se
Contact Person Name
Petter Svenberg
Site Name
Uppsala University Hospital (Akademiska Sjukhuset)
Department Name
Akademiska barnsjukhuset
Principal Investigator Name
Arja Harila
Principal Investigator Email
arja.harila@uu.se
Contact Person Name
Arja Harila
Contact Person Email
arja.harila@uu.se

Italy

Earliest CTIS Part Ii Submission Date
08-11-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
33
Number Of Sites
19
Number Of Participants
40

Sites

Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
U.S.S. Oncoematologia Pediatrica
Principal Investigator Name
Laura Cavalleri
Principal Investigator Email
lauracavalleri@asst-pg23.it
Contact Person Name
Laura Cavalleri
Contact Person Email
lauracavalleri@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Oncoematologia-Pediatrica
Principal Investigator Name
Elena Chiocca
Principal Investigator Email
elena.chiocca@meyer.it
Contact Person Name
Elena Chiocca
Contact Person Email
elena.chiocca@meyer.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Oncoematologia Pediatrica
Principal Investigator Name
Anita Spirito
Principal Investigator Email
a.spirito@operapadrepio.it
Contact Person Name
Anita Spirito
Contact Person Email
a.spirito@operapadrepio.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Dipartimento Ematologia, Oncologia e Trapianto di Midollo
Principal Investigator Name
Daniela Guardo
Principal Investigator Email
danielaguardo@gaslini.org
Contact Person Name
Daniela Guardo
Contact Person Email
danielaguardo@gaslini.org
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Oncoematologia-Pediatrica
Principal Investigator Name
Simone Cesaro
Principal Investigator Email
simone.cesaro@aovr.veneto.it
Contact Person Name
Simone Cesaro
Contact Person Email
simone.cesaro@aovr.veneto.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Clinica pediatrica, Unità di Ematologia Pediatrica
Principal Investigator Name
Veronica Leoni
Principal Investigator Email
veronica.leoni@irccs-sangerardo.it
Contact Person Name
Veronica Leoni
Site Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Oncologia Pediatrica
Principal Investigator Name
Franca Fagioli
Principal Investigator Email
franca.fagioli@unito.it
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Oncoematologia Pediatrica
Principal Investigator Name
Maria Caterina Putti
Principal Investigator Email
mariacaterina.putti@unipd.it
Contact Person Name
Maria Caterina Putti
Contact Person Email
mariacaterina.putti@unipd.it
Site Name
Azienda Ospedaliera Santobono Pausilipon
Department Name
Pediatric Oncology Department
Principal Investigator Name
Rosanna Parasole
Principal Investigator Email
r.parasole@santobonopausilipon.it
Contact Person Name
Rosanna Parasole
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncologia pediatrica
Principal Investigator Name
Francesca Rossi
Principal Investigator Email
Francesca.ROSSI@unicampania.it
Contact Person Name
Francesca Rossi
Contact Person Email
Francesca.ROSSI@unicampania.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Area Studi Clinici Oncoematologici e Terapie Cellulari
Principal Investigator Name
Franco Locatelli
Principal Investigator Email
franco.locatelli@opbg.net
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Oncoematologia Pediatrica
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
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Oncoematologia Pediatrica
Principal Investigator Name
Simona Gobbi
Principal Investigator Email
simona.gobbi@ospedaliriuniti.marche.it
Contact Person Name
Simona Gobbi
Site Name
Azienda Ospedaliero-Universitaria Di Bologna
Department Name
Oncoematologia Pediatrica
Principal Investigator Name
Fraia Melchionda
Principal Investigator Email
fraia.melchionda@aosp.bo.it
Contact Person Name
Fraia Melchionda
Contact Person Email
fraia.melchionda@aosp.bo.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Emato-Oncologia e Centro Trapianti
Principal Investigator Name
Marco Rabusin
Principal Investigator Email
marco.rabusin@burlo.trieste.it
Contact Person Name
Marco Rabusin
Contact Person Email
marco.rabusin@burlo.trieste.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Center of pediatric Hematology Oncology
Principal Investigator Name
Luca Lo Nigro
Principal Investigator Email
lonigro@policlinico.unict.it
Contact Person Name
Luca Lo Nigro
Contact Person Email
lonigro@policlinico.unict.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC di Pediatria ad indirizzo Oncoematologico
Principal Investigator Name
Nicola Santoro
Principal Investigator Email
nico.santoro1956@libero.it
Contact Person Name
Nicola Santoro
Contact Person Email
nico.santoro1956@libero.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Oncoematologia
Principal Investigator Name
Delia Russo
Principal Investigator Email
drdeliarusso@gmail.com
Contact Person Name
Delia Russo
Contact Person Email
drdeliarusso@gmail.com
Site Name
ARNAS G. Brotzu
Department Name
Oncoematologia-Pediatrica
Principal Investigator Name
Rosamaria Mura
Principal Investigator Email
rosamaria.mura@aob.it
Contact Person Name
Rosamaria Mura
Contact Person Email
rosamaria.mura@aob.it

Austria

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
14-12-2025
Processing Time Days
16
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für pädiatrische Hämato-Onkologie
Principal Investigator Name
Daniela Kohlfürst
Principal Investigator Email
daniela.kohlfuerst@medunigraz.at
Contact Person Name
Daniela Kohlfürst
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitätsklinik für Kinder- und Jugendheilkunde
Principal Investigator Name
Neil Jones
Principal Investigator Email
n.jones@salk.at
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
St. Anna Kinderspital GmbH
Department Name
Kinderonkologie
Principal Investigator Name
Andishe Attarbaschi
Principal Investigator Email
andishe.attarbaschi@ccri.at
Contact Person Name
Andishe Attarbaschi
Contact Person Email
andishe.attarbaschi@ccri.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Roman Crazzolara
Principal Investigator Email
roman.crazzolara@tirol-kliniken.at
Contact Person Name
Roman Crazzolara

Norway

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
37
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Helse Bergen HF
Department Name
Children and youth clinic
Principal Investigator Name
Elisabeth Orskov Rotevatn
Principal Investigator Email
elisabeth.orskov.rotevatn@helse-bergen.no
Contact Person Name
Elisabeth Orskov Rotevatn
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Pediatric
Principal Investigator Name
Simon Kranz
Principal Investigator Email
simon.kranz@unn.no
Contact Person Name
Simon Kranz
Contact Person Email
simon.kranz@unn.no
Site Name
Oslo University Hospital HF
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Jochen Büchner
Principal Investigator Email
jocbuc@ous-hf.no
Contact Person Name
Jochen Büchner
Contact Person Email
jocbuc@ous-hf.no
Site Name
St. Olavs Hospital HF
Department Name
Pediatric Hematology and Oncology
Principal Investigator Name
Bendik Lund
Principal Investigator Email
Bendik.lund@stolav.no
Contact Person Name
Bendik Lund
Contact Person Email
Bendik.lund@stolav.no

Denmark

Earliest CTIS Part Ii Submission Date
26-11-2025
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
13
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Region Midtjylland
Department Name
Department of paediatric and adolescent medicine
Principal Investigator Name
Birgitte Klug Albertsen
Principal Investigator Email
biralber@rm.dk
Contact Person Name
Birgitte Klug Albertsen
Contact Person Email
biralber@rm.dk
Site Name
Odense University Hospital
Department Name
Hans Christian Andersen Children's Hospital
Principal Investigator Name
Peder Wehner
Principal Investigator Email
peder.skov.wehner@rsyd.dk
Contact Person Name
Peder Wehner
Contact Person Email
peder.skov.wehner@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of paediatric and adolescent medicine
Principal Investigator Name
Bodil Als-Nielsen
Contact Person Name
Bodil Als-Nielsen

Netherlands

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
11-12-2025
Processing Time Days
27
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Hemato-oncology
Principal Investigator Name
J. Stutterheim
Principal Investigator Email
J.Stutterheim@prinsesmaximacentrum.nl
Contact Person Name
J. Stutterheim

Sponsor

Primary sponsor

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

Contract research organisations

Name
Julius Clinical International B.V.
Responsibilities
Clinical Research Organisation

Third parties

  • {"country":"Italy","full_name":"Ospedale Pediatrico Bambino Gesu","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Austria","full_name":"St. Anna Childrens Cancer Research Institute GmbH","duties_or_roles":"National Coordinating Center","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Amgen GmbH","duties_or_roles":"5","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"HUS-Yhtymae","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Sweden","full_name":"Karolinska University Hospital","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Centre Hospitalier Universitaire De Nice","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Spain","full_name":"Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia","duties_or_roles":"National Coordinating Center","organisation_type":"Educational Institution"}
  • {"country":"Netherlands","full_name":"Prinses Maxima Centrum voor Kinderoncologie B.V.","duties_or_roles":"5","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Czechia","full_name":"Fakultni Nemocnice V Motole","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Pfizer Inc.","duties_or_roles":"5","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Julius Clinical International B.V.","duties_or_roles":"Clinical Research Organisation","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Rigshospitalet","duties_or_roles":"National Coordinating Center","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
INOTUZUMAB OZOGAMICIN
Active Substance
Inotuzumab ozogamicin
Modality
ADC
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
prodAuthStatus=2
Starting Dose
0.8 mg/m2 (max daily dose amount reported: 0.8 mg/m2)
Maximum Dose
1.8 mg/m2 (max total dose amount reported)
Investigational Product Name
BLINATUMOMAB (BLINCYTO)
Active Substance
Blinatumomab
Modality
Bispecific antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
EU marketing authorisation present (prodAuthStatus=2, EU authorisation noted)
Starting Dose
15 µg/m2 (max daily dose amount reported: 15 µg/m2)
Maximum Dose
1.69 (units as in product record)
Combination Treatment
Yes

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