Clinical trial • Phase II • Oncology

INOTUZUMAB OZOGAMICIN for Acute lymphoblastic leukemia | B-cell precursor acute lymphoblastic leukemia

Phase II trial of INOTUZUMAB OZOGAMICIN for Acute lymphoblastic leukemia | B-cell precursor acute lymphoblastic leukemia.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute lymphoblastic leukemia | B-cell precursor acute lymphoblastic leukemia
Trial Stage
Phase II
Drug Modality
ADC
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
16-07-2024
First CTIS Authorization Date
13-08-2024

Trial design

Randomised, open-label, allr3 induction regimen (comparator) including: oncaspar (pegaspargase; oncaspar 750 u/ml powder for solution for injection/infusion), mitoxantrone hydrochloride (concentrate for solution for infusion), vincristine sulfate 1 mg/ml solution for injection, crisantaspase (erwinase), and dexamethasone (oral and injectable formulations). (dose indications present in product data: oncaspar maxdailydoseamount 1000 u/ml; vincristine maxdailydoseamount 1.5 mg/m2; mitoxantrone maxdailydoseamount 10 mg/m2; dexamethasone maxdailydoseamount 20 mg/m2).-controlled Phase II trial in Greece, Austria, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
ALLR3 induction regimen (comparator) including: Oncaspar (pegaspargase; Oncaspar 750 U/ml powder for solution for injection/infusion), MITOXANTRONE HYDROCHLORIDE (concentrate for solution for infusion), Vincristine Sulfate 1 mg/ml solution for injection, CRISANTASPASE (Erwinase), and Dexamethasone (oral and injectable formulations). (Dose indications present in product data: Oncaspar maxDailyDoseAmount 1000 U/ml; Vincristine maxDailyDoseAmount 1.5 mg/m2; Mitoxantrone maxDailyDoseAmount 10 mg/m2; Dexamethasone maxDailyDoseAmount 20 mg/m2).

Eligibility

Recruits 94 paediatric patients.

Pregnancy Exclusion
Diagnostic Assessments: Serum or urine pregnancy test positive at screening.
Vulnerable Population
Paediatric population (participants aged 1 to <18 years). Informed consent is provided by parent(s) or legal guardian(s). Age-specific assent and information materials are used: multiple parent/guardian ICDs and age-appropriate assent forms are provided (examples in the documentation: Assent 6-10 yrs, Assent 11-13 yrs, Assent 13-17 yrs, Assent 12-16 yrs, and other adolescent/child-specific ICDs). Study materials include parent/caregiver ICDs and assent forms across participating countries and languages; optional procedure and retained sample information sheets and pregnancy partner form are also provided.

Inclusion criteria

  • {"criterion_text":"- Male or female participants between 1 and less than 18 years of age."}
  • {"criterion_text":"- Type of Participant and Disease Characteristics: Morphologically confirmed diagnosis of first relapse HR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high risk genetic abnormalities • CD22-positive ALL as defined by local institution; • Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status)."}
  • {"criterion_text":"- Other Inclusion Criteria: Adequate serum chemistry parameters: • An estimated glomerular filtration rate (eGFR) in participants 1 to less than 2 years of age, or estimated creatinine clearance (eCrCl) in those 2 to less than 18 years of age, ≥30 mL/min using the recommended formula • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × institutional ULN at the time of randomization or precytoreduction/ general anesthesia; • Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;"}
  • {"criterion_text":"- Prior history of thrombosis during corticosteroid use and/or asparaginase are eligible provided the participant receives anticoagulant prophylaxis per institutional guidelines."}
  • {"criterion_text":"- Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction > 50% by MUGA."}

Exclusion criteria

  • {"criterion_text":"- Any history of: • Prior or ongoing hepatic SOS or prior liver failure [defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)]; • Prior allo-HSCT or CAR T-cell therapy; • Isolated extramedullary leukemia; • Philadelphia-chromosome positive ALL, ie. BCR-ABL/t(9;22) present; • Presence of Grade 3 or Grade 4 peripheral neuropathy as defined in the Delphi consensus of acute toxic effects for childhood ALL; • Hypersensitivity to the active ingredient of InO or any of its excipients; • Hypersensitivity/allergy to both PEG-ASP and Erwinia-ASP; • Intolerance to any of the ALLR3 agents (mitoxantrone, vincristine, dexamethasone, asparaginase); • Grade 3 or Grade 4 pancreatitis due to any cause, as defined by CTCAE v4.03; • Grade 3 or Grade 4 allergic reaction to a monoclonal antibody; • Participants not fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, defined as resolution of all such non-hematologic toxicities to Grade ≤2 per the NCI CTCAE v 4.03 prior to randomization, with the exception of the laboratory abnormalities as defined by other inclusion/exclusion criteria; • Down syndrome; • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study; • Charcot-Marie-Tooth disease."}
  • {"criterion_text":"- Prior/Concomitant Therapy with: • A calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin) or prior therapy with a CD22 targeted therapy (immunotoxin or CAR T-cell therapy); • Cytotoxic therapy within 7 days prior to enrollment, with the exception of hydroxyurea and corticosteroids which are permitted prior to initiating study intervention. Participants may have receivedintrathecal chemotherapy at any time prior to study entry. NOTE: No waiting period is required for participants who relapse while receiving first-line maintenance chemotherapy. • Any radiation therapy within 28 days prior to enrollment; • The last dose of granulocyte stimulating factor (ie, Neupogen or equivalent) administered within 7 days prior to study enrollment and the last dose of pegfilgrastim (Neulasta®) given within 14 days prior to enrollment; • Less than 3 half-lives elapsed after the last dose of a mAb (eg, rituximab=66 days, epratuzumab=69 days). Participants must not have received blinatumomab within 4 weeks before study enrollment; • Current use of any prohibited concomitant medication(s) or participants unwilling/unable to use a permitted concomitant medication(s); • Any vaccination with live viral vaccines within 2 weeks of the start of study therapy. Prior/Concurrent Clinical Study Experience:"}
  • {"criterion_text":"- Administration of an IP (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). A participant may be eligible if they are in the follow-up phase of an investigational study if they meet the criterion for time elapsed from previous administration of IP. Cases must be discussed with sponsor's medical monitor to judge eligibility."}
  • {"criterion_text":"- Diagnostic Assessments: Serum or urine pregnancy test positive at screening."}
  • {"criterion_text":"- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, STT interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF >470 msec, the ECG should be repeated 2 more times the average of the 3 QTcF values should be used to determine the participant's eligibility. Computer interpreted ECGs should be over read locally by a physician experienced in reading ECGs before excluding participants."}
  • {"criterion_text":"- Participants with active infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness. • HIV infection with CD4+ count <200/mm3 and viral load of >400 copies/mm3. Participants with stable well-controlled HIV infection may be eligible after consultation with the sponsor. HBV • Participants with a positive HBsAg (ie, either acute or chronic active hepatitis) are excluded. • Participants with HBV antibody positivity indicating immunity, either due to vaccination or prior natural infection, are eligible. •Participants with positive anti-HBcAb but negative HBsAg and anti- HBsAb profile, depending on clinical circumstances, may be eligible. Discussion with the sponsor is indicated. HCV • Participants with active HCV as determined by viral load."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Minimal residual disease (MRD)-negative, CR/CRp/CRi (per investigator assessment) at the end of induction therapy (MRD negativity is assessed by central lab and defined as leukemic blasts <1x10-4 by real time quantitative polymerase chain reaction (RQ-PCR) [with reflex to FC result if MRD is non-evaluable by RQ-PCR]).","definition_or_measurement_approach":"MRD negativity is assessed by central lab and defined as leukemic blasts <1x10-4 by real time quantitative polymerase chain reaction (RQ-PCR) [with reflex to FC result if MRD is non-evaluable by RQ-PCR]."}

Secondary endpoints

  • {"endpoint_text":"- EFS, defined as the time from randomization until objective progression, relapse from CR/CRp/CRi, based on investigator assessment per response criteria, failure to achieve CR/CRp/CRi by the end of induction, MRD persistence prior to HSCT, second malignancy, or death due to any cause.","definition_or_measurement_approach":"Defined as time from randomization until objective progression, relapse from CR/CRp/CRi, failure to achieve CR/CRp/CRi by end of induction, MRD persistence prior to HSCT, second malignancy, or death from any cause (investigator assessment per response criteria)."}
  • {"endpoint_text":"- DOR, defined as time from date of first documented response (CR/CRp/CRi) to the date of first documented objective progression, relapse from CR/CRp/CRi as determined by investigator assessment per modified NCCN response criteria, MRD persistence prior to HSCT, or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"Defined as time from first documented response to first documented objective progression, relapse from CR/CRp/CRi, MRD persistence prior to HSCT, or death (investigator assessment per modified NCCN response criteria)."}
  • {"endpoint_text":"- HSCT (and CAR T-cell therapy) rate, defined as the number and percentage of participants being transplanted and those receiving CAR Tcell therapy after treatment with InO or ALLR3.","definition_or_measurement_approach":"Number and percentage of participants who undergo HSCT or receive CAR T-cell therapy after treatment with InO or ALLR3."}
  • {"endpoint_text":"- OS, defined as the time from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"Time from randomization to death from any cause."}
  • {"endpoint_text":"- Incidence and severity of AEs graded per NCI CTCAE v4.03.","definition_or_measurement_approach":"Adverse events graded according to NCI CTCAE v4.03; incidence and severity recorded."}
  • {"endpoint_text":"- Cmax and Ctrough","definition_or_measurement_approach":"Pharmacokinetic measurements: peak concentration (Cmax) and trough concentration (Ctrough)."}

Recruitment

Recruitment Window Months
95
Consent Approach
Informed consent obtained from parent(s)/legal guardian(s). Age-appropriate assent forms and information are used for paediatric participants (documents exist for assent / ICD across age groups such as 6-10 yrs, 11-13 yrs, 13-17 yrs, older adolescent forms and parent/guardian ICDs). Subject information and consent materials are provided in country-specific languages per participating member states (multiple country-specific ICD and assent documents listed). Optional procedure consent and retained sample/RRS information are included where applicable.

Geography

Total Number Of Sites
65
Total Number Of Participants
94

Greece

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
22
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Aghia Sophia Children's Hospital
Department Name
Department of Pediatry, Haematology and Oncology
Contact Person Name
Sophia Polychronopoulou
Contact Person Email
sophpol@otenet.gr

Austria

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
21-07-2025
Processing Time Days
355
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
St. Anna Kinderspital GmbH
Department Name
Hämatologische, Onkologische und Immunologische Abteilung
Contact Person Name
Gernot Engstler
Contact Person Email
gernot.engstler@stanna.at

Belgium

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
16-07-2025
Processing Time Days
350
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
UZ Leuven
Contact Person Name
Heidi Segers
Contact Person Email
heidi.segers@uzleuven.be
Site Name
Universiteit Gent
Department Name
Pediatric Hemato-Oncologogy & Stem Cell Transplant
Contact Person Name
Barbara De Moerloose
Contact Person Email
barbara.demoerloose@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology oncology pediatric
Contact Person Name
Maelle De Ville de Goyet

Denmark

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
20-07-2025
Processing Time Days
352
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Rigshospitalet
Department Name
Department of paediatrics and adolescent medicine
Contact Person Name
Karsten Nysom
Contact Person Email
karsten.nysom@regionh.dk

Finland

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
15-07-2025
Processing Time Days
349
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
HUS-Yhtymae
Contact Person Name
Samppa Ryhänen
Contact Person Email
samppa.ryhanen@hus.fi

Hungary

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
348
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Gyermek-Onkohaematológiai Részleg
Contact Person Name
Agnes Kelemen
Contact Person Email
kelemen.igyek@bazmkorhaz.hu
Site Name
Semmelweis University
Department Name
Gyermekgyogyaszati Klinika
Contact Person Name
Daniel Erdelyi
Site Name
Pécsi Tudományegyetem Klinikai Központ
Department Name
Gyermekgyógyászati Klinika Onkohematológiai Osztály
Contact Person Name
Gabor Ottoffy
Contact Person Email
ottoffy.gabor@pte.hu

Sweden

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
352
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Sahlgrenska Universitetssjukhuset Östra
Contact Person Name
Jonas Abrahamsson
Contact Person Email
jonas.abrahamsson@vregion.se
Site Name
Karolinska University Hospital
Department Name
Cancerstudieenheten, Centrum för Kliniska Cancerstudier, Tema Cancer
Contact Person Name
Petter Svenberg
Site Name
Region Skane Skanes Universitetssjukhus
Contact Person Name
Ladislav Krol
Contact Person Email
Ladislav.Krol@skane.se

Netherlands

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
352
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Contact Person Name
Britta Julia Vormoor

Norway

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
15-07-2025
Processing Time Days
349
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Oslo University Hospital HF
Contact Person Name
Jochen Büchner
Contact Person Email
jocbuc@ous-hf.no

Poland

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
352
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klin.Transplantacji Szpiku Onkologii i Hemat. Dziecięcej
Contact Person Name
Monika Mielcarek-Siedziuk
Contact Person Email
mmielcarek@gmail.com
Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
Klinika Pediatrii, Hematologii i Onkologii
Contact Person Name
Jan Styczynski
Contact Person Email
jstyczynski@cm.umk.pl

Slovakia

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
15-07-2025
Processing Time Days
349
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Narodny Ustav Detskych Chorob
Department Name
Klinika detskej hematologie a onkologie LF UK a NUDCH
Contact Person Name
Alexandra Kolenova
Contact Person Email
sasa.kolenova@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
18-07-2025
Processing Time Days
352
Number Of Sites
11
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera Santobono Pausilipon
Department Name
Dipartimento di Oncologia
Contact Person Name
Rosanna Parasole
Contact Person Email
rparasol64@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
UOC Ematologia
Contact Person Name
Luca Lo Nigro
Contact Person Email
lucalonigro1968@gmail.com
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Oncoematologia Pediatrica
Contact Person Name
Marco Zecca
Contact Person Email
m.zecca@smatteo.pv.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
UOC Onco-Ematologia Pediatrica
Contact Person Name
Delia Russo
Contact Person Email
drdeliarusso@gmail.com
Site Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Department Name
U.O. Pediatria Pession
Contact Person Name
Arcangelo Prete
Contact Person Email
arcangelo.prete@aosp.bo.it
Site Name
Fondazione MBBM - Ematologia Pediatrica
Department Name
Clinica Pediatrica
Contact Person Name
Veronica Leoni
Contact Person Email
vleoni@fondazionembbm.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Hemato-Oncology Unit 3° floor, main building
Contact Person Name
Marco Rabusin
Contact Person Email
marco.rabusin@burlo.trieste.it
Site Name
Azienda Ospedale - Università Padova
Contact Person Name
Alessandra Biffi
Contact Person Email
alessandra.biffi@unipd.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
U.O.C. Oncologia
Contact Person Name
Elena Palmisani
Contact Person Email
elenapalmisani@gaslini.org
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Dipartimento di Onco-Ematologia e Terapia Cellula
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Ospedale Infantile Regina Margherita
Department Name
S.C. Oncoematologia Pediatrica
Contact Person Name
Franca Fagioli
Contact Person Email
franca.fagioli@unito.it

Spain

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
448
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
University Clinical Hospital Virgen De La Arrixaca
Contact Person Name
Jose Luis Fuster Soler
Contact Person Email
josel.fuster@carm.es
Site Name
Hospital Infantil Universitario Nino Jesus
Contact Person Name
Beatriz Vergara Munoz
Site Name
Universidade De Santiago De Compostela
Contact Person Name
Manuel Fernandez Sanmartin
Site Name
Hospital Sant Joan De Deu Barcelona
Contact Person Name
Jose Luis Dapena Diaz
Contact Person Email
joseluis.dapena@sjd.es
Site Name
Hospital Universitario La Paz
Contact Person Name
Berta González Martínez
Site Name
University Hospital Virgen Del Rocio S.L.
Contact Person Name
Agueda Molinos Quintana
Contact Person Email
aguedamolinos@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Contact Person Name
Pablo Velasco Puyo
Site Name
Hospital Universitario Y Politecnico La Fe
Contact Person Name
Carolina Fuentes Socorro
Contact Person Email
fuentes_car@gva.es

France

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
555
Number Of Sites
12
Number Of Participants
15

Sites

Site Name
Centre Hospitalier Universitaire De Rennes
Contact Person Name
Virginie GANDEMER
Site Name
Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)
Contact Person Name
Carine HALFON-DOMENECH
Contact Person Email
carine.halfondomenech@ihope.fr
Site Name
Hôpital Jeanne de Flandre
Department Name
Unite d`hematologie pediatrique
Contact Person Name
Brigitte Neklen
Contact Person Email
brigitte.nelken@chru-lille.fr
Site Name
Trousseau Hospital
Contact Person Name
Arnaud Petit
Contact Person Email
arnaud.petit@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Contact Person Name
Alexandre Theron
Contact Person Email
theron@chu-montpellier.fr
Site Name
Hopital Des Enfants
Contact Person Name
Marlene PASQUET
Contact Person Email
pasquet.m@chu-toulouse.fr
Site Name
CHU de Bordeaux, Hôpital Pellegrin
Contact Person Name
Stephane DUCASSOU
Site Name
CHU Nancy - Hôpital Brabois
Department Name
Service de Dermato-Venereologie
Contact Person Name
Marion LUBNAU
Contact Person Email
m.lubnau@chru-nancy.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Contact Person Name
Catherine PAILLARD
Site Name
Hôpital Archet 2
Contact Person Name
Pierre-Simon ROHRLICH
Contact Person Email
rohrlich.ps@chu-nice.fr
Site Name
Robert Debre University Hospital
Contact Person Name
Marion STRULLU
Contact Person Email
marion.strullu@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Contact Person Name
Rialland Fanny Battisti
Contact Person Email
fanny.rialland@chu-nantes.fr

Germany

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
562
Number Of Sites
14
Number Of Participants
18

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Christin Linderkamp
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Hämatologisch-onkologische Ambulanz (KA04)
Contact Person Name
Florian Babor
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Pädiatrische Hämatologie / Onkologie
Contact Person Name
Christian Reimann
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Pädiatrische Hämatologie, Onkologie, Stammzelltransplantation
Contact Person Name
Gerrit Weber
Contact Person Email
weber_g1@ukw.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Kinder und Jugendmedizin, Hämatologie, Onkologie
Contact Person Name
Jana Ernst
Contact Person Email
jana.ernst@med.uni-jena.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Zentrum für Pädiatrische Hämatologie, Onkologie und Hämostaseologie
Contact Person Name
Jan-Henning Klusmann
Contact Person Email
jan-henning.klusmann@kgu.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Christian Flotho
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Pädiatrische Klinik mit Schwerpunkt Onkologie und Hämatologie
Contact Person Name
Arend von Stackelberg
Contact Person Email
arend.stackelberg@charite.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Abteilung für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Christine Mauz-Koerholz
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Gabriele Escherich
Contact Person Email
escherich@uke.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Tim Flaadt
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Claudia Rössig
Contact Person Email
rossig@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Kinder- und Jugendmedizin I
Contact Person Name
Gunnar Cario
Contact Person Email
Gunnar.Cario@uksh.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Pädiatrische Hämatologie und Onkologie
Contact Person Name
Stefan Schönberger

Czechia

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
603
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika dětské hematologie a onkologie 2. LF UK a FN Motol
Contact Person Name
Lucie Šrámková
Contact Person Email
lucie.sramkova@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika dětské onkologie
Contact Person Name
Danica Zapletalová
Contact Person Email
zapletalova.danica@fnbrno.cz

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Pharmacokinetic (PK) analysis

Third parties

  • {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"Biomarker analysis, during-study storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Pharmacokinetic (PK) analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Kits & lab manual creation & delivery to sites, samples storage and sending to analytical lab.","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Charité - Universitätsmedizin Berlin","duties_or_roles":"Bone Marrow Sample Assessment Minimal Residual Disease (MRD) analysis","organisation_type":"Health care"}

Investigational products

Investigational Product Name
BESPONSA 1 mg powder for concentrate for solution for infusion
Active Substance
INOTUZUMAB OZOGAMICIN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised (marketing authorisation EU/1/17/1200/001)
Maximum Dose
0.8 mg/m2

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