Clinical trial • Phase II/III • Haematology

ISATUXIMAB for Acute lymphoblastic leukaemia | T-lymphoblastic lymphoma

Phase II/III trial of ISATUXIMAB for Acute lymphoblastic leukaemia | T-lymphoblastic lymphoma. Randomised. 1100 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Acute lymphoblastic leukaemia | T-lymphoblastic lymphoma
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody | Bispecific antibody | Small molecule

Key dates

Initial CTIS Submission Date
05-07-2024
First CTIS Authorization Date
25-10-2024

Trial design

Randomised Phase II/III trial in France, Belgium.

Randomised
Yes
Target Sample Size
1100

Eligibility

Recruits 1100 Vulnerable populations not selected in the trial metadata. The protocol excludes "14. Patients under a legal protection regime (guardianship, trusteeship, judicial safeguard)". Study population is adults aged 18-65 and the protocol requires signed written informed consent; no assent process for minors is mentioned..

Pregnancy Exclusion
12. Pregnancy and breast feeding
Vulnerable Population
Vulnerable populations not selected in the trial metadata. The protocol excludes "14. Patients under a legal protection regime (guardianship, trusteeship, judicial safeguard)". Study population is adults aged 18-65 and the protocol requires signed written informed consent; no assent process for minors is mentioned.

Inclusion criteria

  • {"criterion_text":"- 1.\tPatients aged 18 to 65 years old"}
  • {"criterion_text":"- 2.\tNewly diagnosed ALL or T-LL according to the WHO criteria"}
  • {"criterion_text":"- 3.\tImmunophenotypic, cytogenetic and/or FISH and molecular evaluation performed and allowing classifying the patient in one of the Phpos ALL, Phneg BCP-ALL or T-ALL cohorts"}
  • {"criterion_text":"- 4.\tNot previously treated except with corticosteroids and/or intrathecal therapy (prephase)"}
  • {"criterion_text":"- 5.\tECOG performance status ≤2"}
  • {"criterion_text":"- 6.\tPatient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, exams and other requirements of the study"}
  • {"criterion_text":"- 7.\tPatients has signed written inform consent document"}
  • {"criterion_text":"- 8.\tWillingness of women of child-bearing potential (WOCBP) and male subjects whose sexual partners are WOCBP to use an effective form of contraception, i.e. methods with a failure rate of <1% per year when used consistently and correctly, during the study and at least 6 months thereafter"}
  • {"criterion_text":"- 9.Eligible for national health insurance (for french patients)"}

Exclusion criteria

  • {"criterion_text":"- 1.\tPatient previously treated with systemic chemotherapy for ALL, antibody-based therapy or TKI"}
  • {"criterion_text":"- 10.\tConcurrent severe diseases which exclude the administration of therapy"}
  • {"criterion_text":"- 11.\tTreatment with any other investigational agent or participating in another trial within 30 days prior to entering this study"}
  • {"criterion_text":"- 12.\tPregnancy and breast feeding"}
  • {"criterion_text":"- 13.\tPatients unwilling or unable to comply with the protocol"}
  • {"criterion_text":"- 14.\tPatients under a legal protection regime (guardianship, trusteeship, judicial safeguard)"}
  • {"criterion_text":"- 15.\tChronic or current active uncontrolled infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment"}
  • {"criterion_text":"- 16.\tCurrent use of prohibited medication (see Section 7.11) (only GRAAPH)"}
  • {"criterion_text":"- 17.\tKnown hypersensitivity or severe reaction to ponatinib, blinatumomab, isatuximab or their excipients ."}
  • {"criterion_text":"- 18.\tReceipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study"}
  • {"criterion_text":"- 2.\tPatients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention"}
  • {"criterion_text":"- 3.\tHistory or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, coordination/movement disorder, autoimmune disease with CNS involvement, psychosis (with the exception of CNS leukemia that is well controlled with intrathecal therapy)"}
  • {"criterion_text":"- 4.\tPatients with LVEF<50% or other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension)"}
  • {"criterion_text":"- 5.\tIf patients with Phpos ALL (only GRAAPH): •\tComplete left bundle branch block, right bundle branch block plus left anterior hemiblock, bi-fascicular block •\tHistory of or presence of clinically significant ventricular or atrial tachyarrhythmias •\tClinically significant resting bradycardia (< 50 beats per minute) •\tCongenital long QT syndrome or QTcF > 470 msec on screening ECG. If QTc > 470 msec and electrolytes are not within normal ranges before ponatinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion •\tCurrently taking drug(s) that are known to have a risk of causing prolonged QTc or TdP unless the drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system), or the participant can safely discontinue the drug(s) •\tPrevious myocardial infarction within the last 12 months •\tSymptomatic peripheral vascular disease •\t History of ischemic stroke or transient ischemic attacks (TIAs) within the last 12 months •\tSignificant bleeding disorder or thrombophilia unrelated to the underlying malignancy indication for study participation •\tGastrointestinal disorders, such as malabsorption syndrome or any other illness that could affect oral absorption"}
  • {"criterion_text":"- 6.\tPrior documented chronic liver disease. Inadequate hepatic functions defined as AST or ALT > 5 x the institutional upper limit of normal (ULN), or > 5 x ULN unless if considered due to leukemia. Total bilirubin > 1.5 x ULN unless if considered due to leukemia or Gilbert/Meulengracht"}
  • {"criterion_text":"- 7.\tEstimated glomerular filtration rate (GFR) < 50 mL/mn using the MDRD equation"}
  • {"criterion_text":"- 8.\tChronic pancreatitis or acute pancreatitis within 6 months before study start"}
  • {"criterion_text":"- 9.\tKnown diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- •\tGRAALL-2024/B o\tHR patients (phase 3) :OS o\tSR patients (phase 2) : OS •\tGRAALL-2024/T (phase 3) : EFS •\tGRAAPH-2024 (phase 3) : OS","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- •\tOS and RFS in the T-ALL cohorts","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tEFS and RFS in the Phneg/pos ALL cohorts","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tHematological CR rate","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tMRD response (IG/TR and BCR::ABL1 markers) after each treatment cycles","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tEarly mortality at day 30, 60 and 90","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tCumulative incidence of relapse (CIR) and cumulative incidence of non-relapse mortality (CINRM)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tTransplant-related mortality (TRM) and graft-versus-host-disease (GvHD) incidence.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- •\tSafety: number and rate of patients who experience one or more AEs/SAEs Quality-of-Life measured by the generic EQ5D 5L instrument Incremental cost effectiveness and cost utility ratio defined as the difference in total costs divided by the difference in survival and in quality adjusted life years","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Sensitivity analyses: •\tEFS/RFS, CIR, CINRM and OS after censoring patients receiving allo-HSCT in first remission at transplant time","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Sensitivity analyses: •\tEFS/RFS, CIR, CINRM and OS after censoring outcomes at the time of initiation of any subsequent anti-leukemic therapy other than therapies planned in the protocol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Subgroup analyses: •\tAge subgroups (older than 45y, 55y)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Subgroup analyses: •\tALL subgroups according to genomic classification and antigen target expression","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
1100
Recruitment Window Months
120
Consent Approach
Signed written informed consent is required from participants (study population defined as adults aged 18-65). Subject information and informed consent forms for adults are provided (document titles include L1_SIS and ICF_F_adullts-GRAAPH, L1_SIS and ICF_F_adullts-GRAALL-T, L1_SIS and ICF_F_adullts-GRAALL-B and language-specific versions for Belgium). No assent procedures for minors are mentioned.

Geography

Total Number Of Sites
68
Total Number Of Participants
1100

France

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
527
Number Of Sites
57
Number Of Participants
1000

Sites

Site Name
Centre Henri Becquerel
Department Name
Hematology Department
Principal Investigator Name
Emilie LEMASLE
Principal Investigator Email
emilie.lemasle@chb.unicancer.fr
Contact Person Name
Emilie LEMASLE
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Hematology Department
Principal Investigator Name
Sylvain CHANTEPIE
Principal Investigator Email
Chantepie-s@chu-caen.fr
Contact Person Name
Sylvain CHANTEPIE
Contact Person Email
Chantepie-s@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hematology Department
Principal Investigator Name
Thibault LEGUAY
Principal Investigator Email
thibaut.leguay@chu-bordeaux.fr
Contact Person Name
Thibault LEGUAY
Contact Person Email
thibaut.leguay@chu-bordeaux.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology Department
Principal Investigator Name
Ambroise MARCAIS
Principal Investigator Email
ambroise.marcais@aphp.fr
Contact Person Name
Ambroise MARCAIS
Contact Person Email
ambroise.marcais@aphp.fr
Site Name
Centre Hospitalier De Valenciennes
Department Name
Hematology Department
Principal Investigator Name
Sabine TRICOT
Principal Investigator Email
tricot-s@ch-valenciennes.fr
Contact Person Name
Sabine TRICOT
Contact Person Email
tricot-s@ch-valenciennes.fr
Site Name
Centre Hospitalier De Roubaix
Department Name
Clinical Hematology Department
Principal Investigator Name
Julia HIEULLE
Principal Investigator Email
julia.hieulle@ch-roubaix.fr
Contact Person Name
Julia HIEULLE
Contact Person Email
julia.hieulle@ch-roubaix.fr
Site Name
Centre Hospitalier De Troyes
Department Name
Hematology Department
Principal Investigator Name
Alberto SANTAGOSTINO
Principal Investigator Email
alberto.santagostino@hcs-sante.fr
Contact Person Name
Alberto SANTAGOSTINO
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Clinical Hematology Department
Principal Investigator Name
Stefan WICKENHAUSER
Principal Investigator Email
stefan.wickenhauser@chu-nimes.fr
Contact Person Name
Stefan WICKENHAUSER
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Hematology Department
Principal Investigator Name
Emmanuelle TAVERNIER
Principal Investigator Email
emmanuelle.tavernier@chu-st-etienne.fr
Contact Person Name
Emmanuelle TAVERNIER
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hematology Department
Principal Investigator Name
Thomas CLUZEAU
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas CLUZEAU
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Leon Berard
Department Name
Hematology Department
Principal Investigator Name
Emmanuelle Nicolas-Virelizier
Contact Person Name
Emmanuelle Nicolas-Virelizier
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Hematology Department
Principal Investigator Name
Justine DECROOCQ
Principal Investigator Email
justine.decroocq@aphp.fr
Contact Person Name
Justine DECROOCQ
Contact Person Email
justine.decroocq@aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Hematology Department
Principal Investigator Name
Aurélie RAVINET
Principal Investigator Email
aravinet@chu-clermontferrand.fr
Contact Person Name
Aurélie RAVINET
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Hematology Department
Principal Investigator Name
Thorsten BRAUN
Principal Investigator Email
thorsten.braun@aphp.fr
Contact Person Name
Thorsten BRAUN
Contact Person Email
thorsten.braun@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Hematology Department
Principal Investigator Name
Tony MARCHAND
Principal Investigator Email
tony.marchand@chu-rennes.fr
Contact Person Name
Tony MARCHAND
Contact Person Email
tony.marchand@chu-rennes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology service AJA
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
Centre Hospitalier Universitaire De Toulouse
Department Name
Hematology Department
Principal Investigator Name
Suzanne TAVITIAN
Principal Investigator Email
tavitian.suzanne@iuct-oncopole.fr
Contact Person Name
Suzanne TAVITIAN
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Hematology Department
Principal Investigator Name
Magda ALEXIS
Principal Investigator Email
magda.alexis@chr-orleans.fr
Contact Person Name
Magda ALEXIS
Contact Person Email
magda.alexis@chr-orleans.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hematology Department
Principal Investigator Name
Magalie JORIS
Principal Investigator Email
joris.magalie@chu-amiens.fr
Contact Person Name
Magalie JORIS
Contact Person Email
joris.magalie@chu-amiens.fr
Site Name
Institut Gustave Roussy
Department Name
Hematology Department
Principal Investigator Name
Florence PASQUIER
Principal Investigator Email
florence.pasquier@gustaveroussy.fr
Contact Person Name
Florence PASQUIER
Site Name
Centre Hospitalier De Colmar
Department Name
Hematology Department
Principal Investigator Name
Jacques CHAPIRO
Principal Investigator Email
jacques.chapiro@ch-colmar.fr
Contact Person Name
Jacques CHAPIRO
Contact Person Email
jacques.chapiro@ch-colmar.fr
Site Name
Clinique Du Parc
Department Name
Hematology
Principal Investigator Name
Alexandre Payssot
Principal Investigator Email
alexandre.payssot.hematoparc@outlook.fr
Contact Person Name
Alexandre Payssot
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Hematology Department
Principal Investigator Name
Amira MEJRI
Principal Investigator Email
amira.mejri@ghrmsa.fr
Contact Person Name
Amira MEJRI
Contact Person Email
amira.mejri@ghrmsa.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Hematology Department
Principal Investigator Name
Sébastien MAURY
Principal Investigator Email
sebastien.maury@aphp.fr
Contact Person Name
Sébastien MAURY
Contact Person Email
sebastien.maury@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hematology Department
Principal Investigator Name
Céline BERTHON
Principal Investigator Email
celine.berthon@chu-lille.fr
Contact Person Name
Céline BERTHON
Contact Person Email
celine.berthon@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hematology adult
Principal Investigator Name
Emmanuel RAFFOUX
Principal Investigator Email
emmanuel.raffoux@aphp.fr
Contact Person Name
Emmanuel RAFFOUX
Contact Person Email
emmanuel.raffoux@aphp.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Blood Diseases Department
Principal Investigator Name
Mathilde HUNAULT BERGER
Principal Investigator Email
mahunault@chu-angers.fr
Contact Person Name
Mathilde HUNAULT BERGER
Contact Person Email
mahunault@chu-angers.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Hematology Department
Principal Investigator Name
Chantal HIMBERLIN
Principal Investigator Email
chimberlin@chu-reims.fr
Contact Person Name
Chantal HIMBERLIN
Contact Person Email
chimberlin@chu-reims.fr
Site Name
Hopital NOVO
Department Name
Hematology Department
Principal Investigator Name
Ioana VAIDA
Principal Investigator Email
ioana.vaida@ght-novo.fr
Contact Person Name
Ioana VAIDA
Contact Person Email
ioana.vaida@ght-novo.fr
Site Name
Institut Curie
Department Name
Hematology Department
Principal Investigator Name
Jacques VARGAFTIG
Principal Investigator Email
jacques.vargaftig@curie.fr
Contact Person Name
Jacques VARGAFTIG
Contact Person Email
jacques.vargaftig@curie.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Hematology Department
Principal Investigator Name
Gaelle GUILLERM
Principal Investigator Email
gaelle.guillerm@chu-brest.fr
Contact Person Name
Gaelle GUILLERM
Contact Person Email
gaelle.guillerm@chu-brest.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Clinical Hematology Department
Principal Investigator Name
Madalina UZUNOV
Principal Investigator Email
madalina.uzunov@aphp.fr
Contact Person Name
Madalina UZUNOV
Contact Person Email
madalina.uzunov@aphp.fr
Site Name
Centre Hospitalier De Colmar
Department Name
Hematology Department
Principal Investigator Name
Jacques CHAPIRO
Principal Investigator Email
jacques.chapiro@ch-colmar.fr
Contact Person Name
Jacques CHAPIRO
Contact Person Email
jacques.chapiro@ch-colmar.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hematology Department
Principal Investigator Name
Julie GUERDER
Principal Investigator Email
julie.guerder@chu-dijon.fr
Contact Person Name
Julie GUERDER
Contact Person Email
julie.guerder@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology Department
Principal Investigator Name
Maira-Pilar GALLEGO
Contact Person Name
Maira-Pilar GALLEGO
Site Name
Besancon University Hospital Center
Department Name
Hematology Department
Principal Investigator Name
Marion SIMONET-BOISSARD
Principal Investigator Email
msimonet@chu-besancon.fr
Contact Person Name
Marion SIMONET-BOISSARD
Contact Person Email
msimonet@chu-besancon.fr
Site Name
Centre Hospitalier De Versailles
Department Name
Hematology Department
Principal Investigator Name
Philippe ROUSSELOT
Principal Investigator Email
phrousselot@ght78sud.fr
Contact Person Name
Philippe ROUSSELOT
Contact Person Email
phrousselot@ght78sud.fr
Site Name
L’Hopital Alexandra Lepeve
Department Name
Hematology Department
Principal Investigator Name
Adrien DANIEL
Principal Investigator Email
adrien.daniel@ch-dunkerque.fr
Contact Person Name
Adrien DANIEL
Contact Person Email
adrien.daniel@ch-dunkerque.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Clinical Hematology Department
Principal Investigator Name
Martin ELOIT
Principal Investigator Email
m.eloit@chu-tours.fr
Contact Person Name
Martin ELOIT
Contact Person Email
m.eloit@chu-tours.fr
Site Name
Chorale Du Centre Hospitalier De Lens
Department Name
Hematology Department
Principal Investigator Name
Claire BORIES
Principal Investigator Email
cbories@ch-lens.fr
Contact Person Name
Claire BORIES
Contact Person Email
cbories@ch-lens.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hematology Department
Principal Investigator Name
Pascal TURLURE
Principal Investigator Email
pascal.turlure@ch-limoges.fr
Contact Person Name
Pascal TURLURE
Contact Person Email
pascal.turlure@ch-limoges.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinical Hematology Department
Principal Investigator Name
Patrice CHEVALLIER
Principal Investigator Email
Patrice.Chevallier@univ-nantes.fr
Contact Person Name
Patrice CHEVALLIER
Site Name
Centre Hospitalier D Avignon
Department Name
Hematology Department
Principal Investigator Name
Safia CHEBREK
Principal Investigator Email
chebrek.safia@ch-avignon.fr
Contact Person Name
Safia CHEBREK
Contact Person Email
chebrek.safia@ch-avignon.fr
Site Name
Centre Hospitalier De Perpignan
Department Name
Hematology Department
Principal Investigator Name
Alexandre KARANGWA
Principal Investigator Email
alexandre.karangwa@ch-perpignan.fr
Contact Person Name
Alexandre KARANGWA
Site Name
Institut Paoli Calmettes
Department Name
Hematology Department
Principal Investigator Name
Yosr HICHERI
Principal Investigator Email
hicheri@ipc.unicancer.fr
Contact Person Name
Yosr HICHERI
Contact Person Email
hicheri@ipc.unicancer.fr
Site Name
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Department Name
Hematology Department
Principal Investigator Name
Abdelaziz CHAIB
Principal Investigator Email
achaib@ch-aix.fr
Contact Person Name
Abdelaziz CHAIB
Contact Person Email
achaib@ch-aix.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hematology Department
Principal Investigator Name
Karin BILGER
Principal Investigator Email
Karin.bilger@chru-strasbourg.fr
Contact Person Name
Karin BILGER
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hematology Department
Principal Investigator Name
Julie GUERDER
Principal Investigator Email
julie.guerder@chu-dijon.fr
Contact Person Name
Julie GUERDER
Contact Person Email
julie.guerder@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hematology Department
Principal Investigator Name
Maira-Pilar GALLEGO
Contact Person Name
Maira-Pilar GALLEGO
Site Name
Besancon University Hospital Center
Department Name
Hematology Department
Principal Investigator Name
Marion SIMONET-BOISSARD
Principal Investigator Email
msimonet@chu-besancon.fr
Contact Person Name
Marion SIMONET-BOISSARD
Contact Person Email
msimonet@chu-besancon.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hematology Department
Principal Investigator Name
Harmony LEROY
Principal Investigator Email
hleroy@ch-cotebasque.fr
Contact Person Name
Harmony LEROY
Contact Person Email
hleroy@ch-cotebasque.fr
Site Name
Centre Hospital Region Metz Thionville
Department Name
Hematology Department
Principal Investigator Name
Godelieve MEUNIER
Principal Investigator Email
godelieve.meunier@chr-metz-thionville.fr
Contact Person Name
Godelieve MEUNIER
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Pediatric Hematology Department
Principal Investigator Name
Alexandre THERON
Principal Investigator Email
a-theron@chu-montpellier.fr
Contact Person Name
Alexandre THERON
Contact Person Email
a-theron@chu-montpellier.fr

Belgium

Earliest CTIS Part Ii Submission Date
09-01-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
438
Number Of Sites
11
Number Of Participants
100

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Clinical Hematology Department
Principal Investigator Name
Anke DELIE
Principal Investigator Email
anke.delie@uzgent.be
Contact Person Name
Anke DELIE
Contact Person Email
anke.delie@uzgent.be
Site Name
Universitair Ziekenhuis Brussel
Department Name
Hematology Department
Principal Investigator Name
Ann DE BECKER
Principal Investigator Email
ann.debecker@uzbrussel.be
Contact Person Name
Ann DE BECKER
Contact Person Email
ann.debecker@uzbrussel.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology Department
Principal Investigator Name
Bernard DE PRIJCK
Principal Investigator Email
bernard.deprijck@chuliege.be
Contact Person Name
Bernard DE PRIJCK
Contact Person Email
bernard.deprijck@chuliege.be
Site Name
Institut Jules Bordet
Department Name
Hematology Department
Principal Investigator Name
Sebastian WITTNEBEL
Principal Investigator Email
sebastian.wittnebel@hubruxelles.be
Contact Person Name
Sebastian WITTNEBEL
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology Department
Principal Investigator Name
Alexander SCHAUWVLIEGHE
Principal Investigator Email
alexander.schauwvlieghe@azsintjan.be
Contact Person Name
Alexander SCHAUWVLIEGHE
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology Department
Principal Investigator Name
Carlos GRAUX
Principal Investigator Email
carlos.graux@chuuclnamur.uclouvain.be
Contact Person Name
Carlos GRAUX
Site Name
Grand Hopital De Charleroi
Department Name
Hematology department
Principal Investigator Name
Valérie ROBIN
Principal Investigator Email
valerie.robin@ghdc.be
Contact Person Name
Valérie ROBIN
Contact Person Email
valerie.robin@ghdc.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology Department
Principal Investigator Name
Florence VAN OBBERGH
Principal Investigator Email
florence.vanobbergh@saintluc.uclouvain.be
Contact Person Name
Florence VAN OBBERGH
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology Department
Principal Investigator Name
Dries DEEREN
Principal Investigator Email
dries.deeren@azdelta.be
Contact Person Name
Dries DEEREN
Contact Person Email
dries.deeren@azdelta.be
Site Name
CHC MontLegia
Department Name
Hematology Department
Principal Investigator Name
Firas BAYOUDH
Principal Investigator Email
firas.bayoudh@chc.be
Contact Person Name
Firas BAYOUDH
Contact Person Email
firas.bayoudh@chc.be
Site Name
CHU Helora
Department Name
Hematology Department
Principal Investigator Name
Sarah AMAT
Principal Investigator Email
sarah.amat@helora.be
Contact Person Name
Sarah AMAT
Contact Person Email
sarah.amat@helora.be

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Third parties

  • {"country":"","full_name":"INCYTE","duties_or_roles":"","organisation_type":""}
  • {"country":"","full_name":"SANOFI","duties_or_roles":"","organisation_type":""}
  • {"country":"","full_name":"AMGEN","duties_or_roles":"","organisation_type":""}
  • {"country":"","full_name":"[DGOS-INCA] : PHRC-K20-100","duties_or_roles":"","organisation_type":""}

Investigational products

Investigational Product Name
SARCLISA 20mg/mL concentrate for solution for infusion.
Active Substance
ISATUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
Intravenous (solution for infusion)
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
10 mg/kg (max daily dose amount: 10 mg/kg)
Investigational Product Name
Iclusig 15 mg film-coated tablets
Active Substance
PONATINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
45 mg (max daily dose amount: 45 mg)
Investigational Product Name
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Active Substance
BLINATUMOMAB
Modality
Bispecific antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
Intravenous (solution for infusion)
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
28 µg (max daily dose amount: 28 µg)
Combination Treatment
Yes

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