Clinical trial • Phase III • Haematology

Ponatinib for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL)

Phase III trial of Ponatinib for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL).

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL)
Trial Stage
Phase III
Drug Modality
Small molecule|Bispecific antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
05-09-2024
First CTIS Authorization Date
01-10-2024

Trial design

Randomised, chemotherapy combined with imatinib (control arm). Phase III trial in Italy.

Randomised
Yes
Comparator
Chemotherapy combined with Imatinib (control arm).
Target Sample Size
236

Eligibility

Recruits 236 Vulnerable population selected (isVulnerablePopulationSelected = true). Consent requirement: "Signed written informed consent according to ICH/EU/GCP and national local laws." Subject information and informed consent form documents are listed (L1/L2). No details on assent or minor consent procedures are provided (study population specifies adults =18 years)..

Pregnancy Exclusion
Negative pregnancy test in women of childbearing potential. | Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Consent requirement: "Signed written informed consent according to ICH/EU/GCP and national local laws." Subject information and informed consent form documents are listed (L1/L2). No details on assent or minor consent procedures are provided (study population specifies adults =18 years).

Inclusion criteria

  • {"criterion_text":"- Signed written informed consent according to ICH/EU/GCP and national local laws.\n- Negative pregnancy test in women of childbearing potential.\n- Bone marrow specimen from primary diagnosis available.\n- Newly diagnosed adult B-precursor Ph+ ALL patients.\n- WHO performance status less or equal to 2.\n- Age greater or equal to18 years, with no upper age limit.\n- Renal and hepatic function as defined below: - AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN). - Total bilirubin <1.5 x ULN. - Creatinine clearance equal or greater than 50 mL/min.\n- Pancreatic function as defined below: - Serum amylase less or equal to 1.5 x ULN and serum lipase less or equal to1.5 x ULN.\n- Normal cardiac function.\n- No evidence of CNS leukemia at blinatumomab start.\n- Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test."}

Exclusion criteria

  • {"criterion_text":"- History of or current relevant CNS pathology (ongoing grade =2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).\n- Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma \"in situ\" of the cervix.\n- Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.\n- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.\n- Impaired cardiac function, including any one of the following: - LVEF <45% as determined by MUGA scan or echocardiogram. - Complete left bundle branch block. - Use of a cardiac pacemaker. - ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. - Congenital long QT syndrome. - History of or presence of significant ventricular or atrial arrhythmia. - Clinically significant resting bradycardia (<50 beats per minute). - QTc >450 msec on screening ECG (using the QTcF formula). - Right bundle branch block plus left anterior hemiblock, bifascicular block. - Myocardial infarction within 3 months prior to starting Ponatinib. - Angina pectoris.\n- Other clinically significant vascular and heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).\n- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Ponatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).\n- Taking medications that are known to be associated with Torsades de Pointes and medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.\n- History of or current autoimmune disease.\n- Systemic cancer chemotherapy within 2 weeks prior to study.\n- Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint of this study is to evaluate the efficacy of a sequential approach based on the administration of Ponatinib plus and Blinatumomab vs chemotherapy combined with Imatinib, in terms of (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit).","definition_or_measurement_approach":"Event-free survival (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development)."}

Secondary endpoints

  • {"endpoint_text":"- The feasibility of patients’ stratification to allo-SCT allocation on the basis of a refined MRD evaluation and on the presence/absence of IKZF1-plus).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Capability of Blinatumomab to further reduce the MRD levels after Ponatinib induction.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CMR or PNQ duration.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- DFS at 1 and 3 years.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- OS at 1 and 3 years.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- CIR.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Safety profile. Safety profile in terms of incidence of grade =3 CTC-NCI side effects and toxicities.","definition_or_measurement_approach":"Incidence of grade ≥3 adverse events according to CTC-NCI criteria."}
  • {"endpoint_text":"- Comparison of patients’ quality of life (QoL) profiles over time by randomization arms.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
236
Recruitment Window Months
82
Consent Approach
Signed written informed consent according to ICH/EU/GCP and national local laws. Subject information and informed consent forms (L1 and L2) are listed in the documents. Participants are adults (>=18 years); no assent procedures for minors provided.

Geography

Total Number Of Sites
78
Total Number Of Participants
236

Italy

Earliest CTIS Part Ii Submission Date
27-10-2023
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
887
Number Of Sites
78
Number Of Participants
236

Sites

Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
UOC EMATOLOGIA E TRAPIANTO DI CELLULE STAMINALI
Contact Person Name
Daniele Armiento
Contact Person Email
d.armiento@unicampus.it
Site Name
Azienda Ospedaliera di Padova
Department Name
DIPARTIMENTO DI EMATOLOGIA ED IMMUNOLOGIA CLINICA
Contact Person Name
Silvia Imbergamo
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
DIPARTIMENTO AREA MEDICA ED ONCOLOGIA
Contact Person Name
Marco De Gobbi
Contact Person Email
marco.degobbi@unito.it
Site Name
Central Hospital Of Bolzano
Department Name
SC EMATOLOGIA E CENTRO TRAPIANTO MIDOLLO OSSEO
Contact Person Name
Federico Mosna
Contact Person Email
federico.mosna@sabes.it
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO E RADIOTERAPICO
Contact Person Name
Caterina Alati
Contact Person Email
caterina.alati@gmail.com
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
DIPARTIMENTO BIOMEDICO DI MEDICINA INTERNA E SPECIALISTICA
Contact Person Name
Sergio Siragusa
Contact Person Email
sergio.siragusa@unipa.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA
Contact Person Name
Albana Lico
Contact Person Email
albana.lico@aulss8.veneto.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
DIPARTIMENTO DI ONCO-EMATOLOGIA
Contact Person Name
Mariachiara Abbenante
Contact Person Email
m.abbenante@operapadrepio.it
Site Name
ASST Valle Olona
Department Name
DIPARTIMENTO ONCOLOGICO
Contact Person Name
Elisabetta Todisco
Site Name
University of Trieste Maggiore Hospital
Department Name
DAI EMATOLOGIA, ONCOLOGIA E INFETTIVOLOGIA
Contact Person Name
Francesco Zaja
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
DIPARTIMENTO DI MEDICINA
Contact Person Name
Maria Ilaria Del Principe
Contact Person Email
del.principe@med.uniroma2.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
DIPARTIMENTO DI SCIENZE MEDICHE, CHIRURGICHE E NEUROSCIENZE
Contact Person Name
Monica Bocchia
Contact Person Email
bocchia@unisi.it
Site Name
Ospedale Fabrizio Spaziani
Department Name
EMATOLOGIA
Contact Person Name
Vincenza Martini
Contact Person Email
vincenzamartini@inwind.it
Site Name
Ospedale Valduce
Department Name
DIPARTIMENTO MEDICO
Contact Person Name
Mauro Turrini
Contact Person Email
mturrini@valduce.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
DIPARTIMENTO DI MEDICINA INTERNA
Contact Person Name
Nicola Fracchiolla
Site Name
Ospedale S G Moscati
Department Name
UOC EMATOLOGIA
Contact Person Name
Lara Aprile
Contact Person Email
lara.aprile@asl.taranto.it
Site Name
Azienda Ospedaliera S Giovanni Addolorata
Department Name
DIPARTIMENTO SPECIALITÀ
Contact Person Name
Michele Cedrone
Contact Person Email
mcedrone@hsangiovanni.roma.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
ONCOLOGIA MEDICA
Contact Person Name
Marianna Norata
Contact Person Email
marianna.norata@irst.emr.it
Site Name
Azienda Sanitaria Locale Br
Department Name
UO EMATOLOGIA
Contact Person Name
Domenico Pastore
Contact Person Email
domenico.pastore0@gmail.com
Site Name
San Camillo Forlanini Hospital
Department Name
DIPARTIMENTO ONCOLOGIA E MEDICINE SPECIALISTICHE
Contact Person Name
Michela Lamanda
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
DIPARTIMENTO ONCOEMATOLOGICO
Contact Person Name
Anna Maria Mianulli
Contact Person Email
amianulli@auslrn.net
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
DIPARTIMENTO TERAPIE ONCOLOGICHE INTEGRATE
Contact Person Name
Germana Beltrami
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Polo Oncologico - UO EMATOLOGIA
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
DIPARTIMENTO DI ONCOLOGIA
Contact Person Name
Giuseppe Lanzarone
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
EMATOLOGIA, ONCOLOGIA E MEDICINA TRASFUSIONALE
Contact Person Name
Marco Rossi
Contact Person Email
rossim@unicz.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
DIPARTIMENTO DI ONCOLOGIA CLINICA
Contact Person Name
Erika Borlenghi
Contact Person Email
erika.borlenghi@gmail.com
Site Name
Careggi University Hospital
Department Name
DIPARTIMENTO DI MEDICINA SPERIMENTALE E CLINICA
Contact Person Name
Barbara Scappini
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
DIPARTIMENTO ONCO EMATOLOGICO
Contact Person Name
Carmine Selleri
Contact Person Email
cselleri@unisa.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE (DIMES)
Contact Person Name
Cristina Papayannidis
Contact Person Email
cristina.papayannidis@unibo.it
Site Name
Azienda Sanitaria Territoriale Di Ascoli Piceno
Department Name
UOC EMATOLOGIA
Contact Person Name
Piero Galieni
Contact Person Email
piero.galieni@sanita.marche.it
Site Name
ASL DELLA PROVINCIA DI BARLETTA, ANDRIA, TRANI, OSPEDALE "MONS. DIMICCOLI" - BARLETTA
Department Name
UO EMATOLOGIA
Contact Person Name
Giuseppe Tarantini
Contact Person Email
Giuseppe.Tarantini@aslbat.it
Site Name
ASSL Nuoro - Ospedale San Francesco
Department Name
UO EMATOLOGIA E CENTRO TRAPIANTI MIDOLLO OSSEO
Contact Person Name
Antonella Cucca
Contact Person Email
anto.cucca@gmail.com
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
DIPARTIMENTO ONCOLOGIA
Contact Person Name
Patrizia Zappasodi
Contact Person Email
p.zappasodi@smatteo.pv.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
DIPARTIMENTO SCIENZE ONCOLOGICHE
Contact Person Name
Agostino Tafuri
Site Name
AORN San Giuseppe Moscati Avellino
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO
Contact Person Name
Lidia Santoro
Contact Person Email
lidiasantoro63@libero.it
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
DIPARTIMENTO ONCOLOGIA - EMATOLOGIA
Contact Person Name
Daniele Vallisa
Contact Person Email
d.vallisa@ausl.pc.it
Site Name
ULSS3 SERENISSIMA - Ospedale dell'Angelo di Mestre
Department Name
UO EMATOLOGIA
Contact Person Name
Cristina Skert
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UO EMATOLOGIA E CTA
Contact Person Name
Monica Fumagalli
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
DIPARTIMENTO ONCOLOGICO
Contact Person Name
Alfredo Molteni
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
SC EMATOLOGIA
Contact Person Name
Daniele Mattei
Contact Person Email
mattei.d@ospedale.cuneo.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
DIPARTIMENTO DI ONCOLOGIA
Contact Person Name
Antonio Mulè
Contact Person Email
a.mule@villasofia.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
AREA ONCOLOGICA
Contact Person Name
Fabio Ciceri
Contact Person Email
ciceri.clinicaltrials@hsr.it
Site Name
Ospedale S. Eugenio, ASL Roma 2
Department Name
DIPARTIMENTO DELLE SPECIALITÀ
Contact Person Name
Carla Mazzone
Contact Person Email
carla.mazzone@aslroma2.it
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
DIPARTIMENTO DI MEDICINA SPECIALISTICA
Contact Person Name
Claudia Maria Basilico
Site Name
Azienda Ospedaliera Papardo
Department Name
SC EMATOLOGIA
Contact Person Name
Donato Mannina
Contact Person Email
donamanni@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
DIMECS E DIPARTIMENTO ONCOLOGICO
Contact Person Name
Monia Lunghi
Contact Person Email
monia.lunghi@med.unipmn.it
Site Name
Ospedale Santa Maria Goretti Latina
Department Name
UOC EMATOLOGIA
Contact Person Name
Alessandro Pulsoni
Contact Person Email
alessandro.pulsoni@uniroma1.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Department Name
DIVISIONE DI EMATOLOGIA
Contact Person Name
Alessandro Isidori
Site Name
La Maddalena S.p.A.
Department Name
DIPARTIMENTO ONCOLOGICO
Contact Person Name
Maurizio Musso
Contact Person Email
musso@lamaddalenanet.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE
Contact Person Name
Sabina Chiaretti
Contact Person Email
chiaretti@bce.uniroma1.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
MEDICINE SPECIALISTICHE E ONCOLOGIA MEDICA
Contact Person Name
Alessandro Allegra
Contact Person Email
aallegra@unime.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
EMATOLOGIA E TRAPIANTO MIDOLLO OSSEO
Contact Person Name
Maria Paola Martelli
Contact Person Email
maria.martelli@unipg.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
DIPARTIMENTO ONCOLOGICO-EMATOLOGICO
Contact Person Name
Prassede Salutari
Contact Person Email
prassede.salutari@ausl.pe.it
Site Name
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Department Name
DIPARTIMENTO DELL'EMERGENZA E DEI TRAPIANTI DI ORGANI (D.E.T.O.)
Contact Person Name
Pellegrino Musto
Contact Person Email
pellegrino.musto@uniba.it
Site Name
ASL Caserta - Moscati Hospital
Department Name
UO ONCOEMATOLOGIA
Contact Person Name
Giuseppe Rodolfo Nunziata
Contact Person Email
grnunziata@gmail.com
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO
Contact Person Name
Lorella Melillo
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA
Contact Person Name
Valentina Mancini
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
Contact Person Name
Patrizia Chiusolo
Contact Person Email
patrizia.chiusolo@unicatt.it
Site Name
ARNAS G. Brotzu
Department Name
SC EMATOLOGIA E CTMO
Contact Person Name
Claudio Romani
Contact Person Email
claudio.romani@aob.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
DIPARTIMENTO DI MEDICINA CLINICA E SPERIMENTALE - DIVISIONE DI EMATOLOGIA
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@med.unipi.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
DIPARTIMENTO ONCOEMATOLOGICO
Contact Person Name
Francesco Lanza
Contact Person Email
francesco.lanza@auslromagna.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
DIPARTIMENTO INTERNISTICO E DI EMERGENZA-URGENZA E ACCETTAZIONE STRUTTURALE
Contact Person Name
Daniela Pietrasanta
Contact Person Email
dpietrasanta@ospedale.al.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
AREA MEDICINA ONCOLOGICA
Contact Person Name
Antonio Spadea
Contact Person Email
antonio.spadea@ifo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
UO EMATOLOGIA
Contact Person Name
Crescenza Pasciolla
Contact Person Email
c.pasciolla@oncologico.bari.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO E PNEUMOEMATOLOGICO
Contact Person Name
Mario Annunziata
Site Name
Istituto Clinico Humanitas
Department Name
CANCER CENTER
Contact Person Name
Matteo Giovanni Della Porta
Contact Person Email
matteo.della_porta@hunimed.eu
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE
Contact Person Name
Daniela Cilloni
Contact Person Email
daniela.cilloni@unito.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
DAI MEDICO GENERALE
Contact Person Name
Massimiliano Bonifacio
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, MATERNO-INFANTILI DELL'ADULTO
Contact Person Name
Mario Luppi
Contact Person Email
mario.luppi@unimore.it

Sponsor

Primary sponsor

Full Name
Fondazione Gimema Franco Mandelli Onlus
Organisation Type
Health care
Country Of Registered Address
Italy

Third parties

  • {"country":"Italy","full_name":"Laboratorio di Ematologia, Policlinico Umberto I, Dip. Medicina Traslazionale e di Precisione","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}

Investigational products

Investigational Product Name
Iclusig 15 mg film-coated tablets
Active Substance
Ponatinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 2)
Orphan Designation
Yes
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
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus 2)
Investigational Product Name
Glivec 100 mg hard capsules
Active Substance
Imatinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 2)
Combination Treatment
Yes

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