Clinical trial • Phase IV • Haematology
Imatinib for Chronic myeloid leukemia (chronic phase)
Phase IV trial of Imatinib for Chronic myeloid leukemia (chronic phase).
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Chronic myeloid leukemia (chronic phase)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-06-2024
- First CTIS Authorization Date
- 08-07-2024
Trial design
Imatinib (Glivec 100 mg hard capsules; reported max daily dose 400 mg) versus Nilotinib (Tasigna 150 mg hard capsules; reported max daily dose 600 mg). Dosing schedule details not specified in the CTIS record.-controlled Phase IV trial in Netherlands, Italy.
- Comparator
- Imatinib (Glivec 100 mg hard capsules; reported max daily dose 400 mg) versus Nilotinib (Tasigna 150 mg hard capsules; reported max daily dose 600 mg). Dosing schedule details not specified in the CTIS record.
- Target Sample Size
- 450
- Trial Duration For Participant
- 1825
Eligibility
Recruits 450 Vulnerable population selected. Written informed consent required: 'Written informed consent prior to any study procedures.' Refusal to give informed consent is an exclusion criterion. Age eligibility is ≥ 18 years (no assent or minor consent provisions described)..
- Pregnancy Exclusion
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
- Vulnerable Population
- Vulnerable population selected. Written informed consent required: 'Written informed consent prior to any study procedures.' Refusal to give informed consent is an exclusion criterion. Age eligibility is ≥ 18 years (no assent or minor consent provisions described).
Inclusion criteria
- {"criterion_text":"- Patients eligible for inclusion in this study have to meet all of the following criteria: • Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase o Documented chronic phase CML must meet all the following criteria: 1. < 15% blasts in peripheral blood 2. < 30% blasts plus promyelocytes in peripheral blood 3. < 20% basophils in the peripheral blood 4. = 100 x 109/L (= 100,000/mm3) platelets\n- Age =18\n- ECOG performance status of 0-2\n- Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR\n- Adequate end organ function as defined by: o Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab). Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade < 3 o SGOT (AST) and SGPT (ALT) = 3 x ULN o Serum amylase and lipase = 2 x ULN o Alkaline phosphatase = 2.5 x ULN o Serum creatinine < 1.5 x ULN\n- Written informed consent prior to any study procedures."}
Exclusion criteria
- {"criterion_text":"- Previous treatment with BCR-ABL inhibitors for more than 30 days.\n- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.\n- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment\n- Patients unable to understand and to comply with study instructions and requirements\n- Refusal to give informed consent.\n- Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.\n- Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for more than three months.\n- Poorly controlled diabetes mellitus (defined as HbA1c >8%\n- Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina as defined at page 30 in Exclusion Criteria.\n- Uncontrolled hypertension\n- History of peripheral arterial occlusive disease.\n- History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis\n- Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which cannot be either discontinued or switched to a different medication prior to starting study drug"}
Endpoints
Primary endpoints
- {"endpoint_text":"- To evaluate the rates of molecular response (MR4.5) at 24 months","definition_or_measurement_approach":"Molecular response MR4.5 at 24 months assessed by molecular monitoring (patients require evidence of BCR-ABL transcripts amenable to standardized RQ-PCR as per inclusion criteria)."}
- {"endpoint_text":"- To evaluate the rates of molecular response (MR4.5) at 24 months - To evaluate the rate of patients who remain in sustained treatment free remission (=MR3.0) without molecular relapse 12 months after entering the TFR phase. The molecular relapse is defined as loss of MMR, or confirmed loss of MR3.0","definition_or_measurement_approach":"Assess MR4.5 at 24 months by molecular monitoring (standardized RQ-PCR). Sustained treatment-free remission defined as ≥ MR3.0 without molecular relapse 12 months after entering TFR phase; molecular relapse defined in-protocol as loss of MMR or confirmed loss of MR3.0."}
Secondary endpoints
- {"endpoint_text":"- To determine the depth of molecular response by 4 years.","definition_or_measurement_approach":"Depth of molecular response assessed by molecular monitoring up to 4 years (standardized RQ-PCR)."}
- {"endpoint_text":"- To estimate progression-free survival (PFS) in the two arms of the study at 60 months","definition_or_measurement_approach":"Progression-free survival estimated at 60 months using clinical and laboratory assessments per protocol."}
- {"endpoint_text":"- To estimate the Overall Survival in the two arms of the study at 60 months","definition_or_measurement_approach":"Overall survival estimated at 60 months (time to death from any cause)."}
- {"endpoint_text":"- To determine the rates of major molecular response (MR3.0) at 1, 2, 3, and 4 year in the two arms of the study.","definition_or_measurement_approach":"MR3.0 rates at specified yearly timepoints assessed by standardized molecular testing (RQ-PCR)."}
- {"endpoint_text":"- The dynamics of molecular response","definition_or_measurement_approach":"Kinetics/dynamics of molecular response assessed via repeated molecular monitoring (RQ-PCR) over time."}
- {"endpoint_text":"- The relationship between baseline characteristics and the achievement of MR4.5 (after treatment NIL frontline therapy vs IM followed by switch to NIL) and the sustained treatment free remission rate (=MR3.0);","definition_or_measurement_approach":"Correlative analyses relating baseline characteristics to MR4.5 achievement and sustained TFR (≥MR3.0) as defined in protocol."}
- {"endpoint_text":"- The relationship between early molecular response and the achievement of MR4.5 (after treatment NIL frontline therapy vs IM followed by switch to NIL) and the sustained treatment free remission rate (=MR3.0)","definition_or_measurement_approach":"Analyses correlating early molecular response measures with later MR4.5 and sustained TFR outcomes using serial molecular assessments."}
- {"endpoint_text":"- To assess the safety profile of either NIL and IM arms","definition_or_measurement_approach":"Safety assessed by collection of adverse events, laboratory tests, and clinical assessments per protocol."}
- {"endpoint_text":"- To determine the rate and the time-distribution of the discontinuation of the firstline TKI, for side-effects, toxicity and AEs.","definition_or_measurement_approach":"Rates and timing of TKI discontinuation due to side-effects/toxicity/AEs captured and summarized over study duration."}
- {"endpoint_text":"- To investigate quality of life (QoL) differences between treatment arms over time","definition_or_measurement_approach":"Quality of life differences assessed longitudinally using QoL instruments described in study documents."}
Recruitment
- Planned Sample Size
- 450
- Recruitment Window Months
- 110
- Consent Approach
- Written informed consent by the participant (age ≥ 18) is required prior to any study procedures ('Written informed consent prior to any study procedures.'). Subject information and ICF documents in the CTIS listing are labelled with '_IT' (Italian); no assent or minor consent procedures are described.
Geography
- Total Number Of Sites
- 45
- Total Number Of Participants
- 450
Netherlands
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 12
- Number Of Sites
- 7
- Number Of Participants
- 26
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Radboud UMC, dept. Hematology/ Amsterdam UMC
- Principal Investigator Name
- M. Donker
- Principal Investigator Email
- m.donker@amsterdamumc.nl
- Contact Person Name
- M. Donker
- Contact Person Email
- m.donker@amsterdamumc.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- ASZ Dordrecht dept. Internal medicine
- Principal Investigator Name
- P. Westerveel
- Principal Investigator Email
- p.e.westerweel@asz.nl
- Contact Person Name
- P. Westerveel
- Contact Person Email
- p.e.westerweel@asz.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Reinier de Graaf Gasthuis, dept. Internal medicine
- Principal Investigator Name
- R.E. Brouwer
- Principal Investigator Email
- rolf.brouwer@rdgg.nl
- Contact Person Name
- R.E. Brouwer
- Contact Person Email
- rolf.brouwer@rdgg.nl
- Site Name
- Jeroen Bosch Ziekenhuis
- Department Name
- Jeroen Bosch Ziekenhuis, dept. Internal medicine
- Principal Investigator Name
- A. Herbers
- Principal Investigator Email
- a.herbers@jbz.nl
- Contact Person Name
- A. Herbers
- Contact Person Email
- a.herbers@jbz.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Spaarne ziekenhuis, dept. Internal medicine
- Principal Investigator Name
- I. Houtenbos
- Principal Investigator Email
- WetenschapsBureau@spaarnegasthuis.nl
- Contact Person Name
- I. Houtenbos
- Contact Person Email
- WetenschapsBureau@spaarnegasthuis.nl
- Site Name
- Meander Medisch Centrum
- Department Name
- UMC Groningen, dept. Hematology
- Principal Investigator Name
- S.K. Klein
- Principal Investigator Email
- s.k.klein@umcg.nl
- Contact Person Name
- S.K. Klein
- Contact Person Email
- s.k.klein@umcg.nl
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Atrium MC loc. Heerlen, dept. Internal medicine
- Principal Investigator Name
- A. Jie
- Principal Investigator Email
- a.jie@zuyderland.nl
- Contact Person Name
- A. Jie
- Contact Person Email
- a.jie@zuyderland.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 11-04-2025
- Processing Time Days
- 289
- Number Of Sites
- 38
- Number Of Participants
- 424
Sites
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- DAI MEDICO GENERALE - UOC EMATOLOGIA
- Principal Investigator Name
- Massimiliano Bonifacio
- Principal Investigator Email
- massimiliano.bonifacio@univr.it
- Contact Person Name
- Massimiliano Bonifacio
- Contact Person Email
- massimiliano.bonifacio@univr.it
- Site Name
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- DIPARTIMENTO DI ONCOLOGIA - SC ONCO EMATOLOGIA
- Principal Investigator Name
- Gaetano Vaudo
- Principal Investigator Email
- vaudogaetano@gmail.com
- Contact Person Name
- Gaetano Vaudo
- Contact Person Email
- vaudogaetano@gmail.com
- Site Name
- ULSS 6 EUGANEA, OSPEDALE CAMPOSAMPIERO - CITTADELLA
- Department Name
- DIPARTIMENTO DI EMATOLOGIA
- Principal Investigator Name
- Franscesca Capraro
- Principal Investigator Email
- francesca.capraro@aulss6.veneto.it
- Contact Person Name
- Franscesca Capraro
- Contact Person Email
- francesca.capraro@aulss6.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- DIPARTIMENTO MEDICINA GENERALE E SPECIALISTICO
- Principal Investigator Name
- Monica Crugnola
- Principal Investigator Email
- mcrugnola@ao.pr.it
- Contact Person Name
- Monica Crugnola
- Contact Person Email
- mcrugnola@ao.pr.it
- Site Name
- AULSS 5 POLESANA, PRESIDIO OSPEDALIERO DI ROVIGO
- Department Name
- DIPARTIMENTO STRUTTURALE OSPEDALIERO MEDICO GENERALE – ROVIGO E TRECENTA
- Principal Investigator Name
- Rossella Paolini
- Principal Investigator Email
- rossella.paolini@aulss5.veneto.it
- Contact Person Name
- Rossella Paolini
- Contact Person Email
- rossella.paolini@aulss5.veneto.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- DIPARTIMENTO DI MEDICINA SPECIALISTICA
- Principal Investigator Name
- Mario Tiribelli
- Principal Investigator Email
- mario.tiribelli@uniud.it
- Contact Person Name
- Mario Tiribelli
- Contact Person Email
- mario.tiribelli@uniud.it
- Site Name
- ASL DELLA PROVINCIA DI BARLETTA, ANDRIA, TRANI, OSPEDALE "MONS. DIMICCOLI" - BARLETTA
- Department Name
- UO EMATOLOGIA
- Principal Investigator Email
- giuseppe.Tarantini@aslbat.it
- Contact Person Email
- giuseppe.Tarantini@aslbat.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- DIPARTIMENTO ONCO-EMATOLOGICO E PNEUMOEMATOLOGICO
- Principal Investigator Name
- Mario Annunziata
- Principal Investigator Email
- mario.annunziata@aocardarelli.it
- Contact Person Name
- Mario Annunziata
- Contact Person Email
- mario.annunziata@aocardarelli.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
- Department Name
- DIPARTIMENTO INTERNISTICO E DI EMERGENZA-URGENZA E ACCETTAZIONE STRUTTURALE
- Principal Investigator Name
- Monia Marchetti
- Principal Investigator Email
- monia.marchetti@ospedale.al.it
- Contact Person Name
- Monia Marchetti
- Contact Person Email
- monia.marchetti@ospedale.al.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- DIPARTIMENTO ONCOLOGICO MEDICO SPECIALISTICO
- Principal Investigator Name
- Francesco Cavazzini
- Principal Investigator Email
- cvzfnc@unife.it
- Contact Person Name
- Francesco Cavazzini
- Contact Person Email
- cvzfnc@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, MATERNO-INFANTILI DELL'ADULTO - SC EMATOLOGIA
- Principal Investigator Name
- Roberto Marasca
- Principal Investigator Email
- roberto.marasca@unimore.it
- Contact Person Name
- Roberto Marasca
- Contact Person Email
- roberto.marasca@unimore.it
- Site Name
- Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA - SC EMATOLOGIA 2
- Principal Investigator Name
- Valentina Giai
- Principal Investigator Email
- vgiai@cittadellasalute.to.it
- Contact Person Name
- Valentina Giai
- Contact Person Email
- vgiai@cittadellasalute.to.it
- Site Name
- Careggi University Hospital
- Department Name
- DIPARTIMENTO DI MEDICINA SPERIMENTALE E CLINICA - SOD EMATOLOGIA
- Principal Investigator Name
- Antonella Gozzini
- Principal Investigator Email
- antonella.gozzini@unifi.it
- Contact Person Name
- Antonella Gozzini
- Contact Person Email
- antonella.gozzini@unifi.it
- Site Name
- ARNAS G. Brotzu
- Department Name
- SC EMATOLOGIA E CTMO
- Principal Investigator Name
- Giovanni Caocci
- Principal Investigator Email
- giovanni.caocci@unica.it
- Contact Person Name
- Giovanni Caocci
- Contact Person Email
- giovanni.caocci@unica.it
- Site Name
- Ospedale Vito Fazzi Lecce
- Department Name
- POLO ONCOLOGICO “GIOVANNI PAOLO II” - UO Ematologia
- Principal Investigator Name
- Nicola Di Renzo
- Principal Investigator Email
- direnzo.ematolecce@gmail.com
- Contact Person Name
- Nicola Di Renzo
- Contact Person Email
- direnzo.ematolecce@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- DIPARTIMENTO AREA MEDICA ED ONCOLOGIA
- Principal Investigator Name
- Marco De Gobbi
- Principal Investigator Email
- marco.degobbi@unito.it
- Contact Person Name
- Marco De Gobbi
- Contact Person Email
- marco.degobbi@unito.it
- Site Name
- Ospedale S. Eugenio, ASL Roma 2
- Department Name
- DIPARTIMENTO DELLE SPECIALITÀ
- Principal Investigator Name
- Elisabetta Abruzzese
- Principal Investigator Email
- elisabetta.abruzzese@uniroma2.it
- Contact Person Name
- Elisabetta Abruzzese
- Contact Person Email
- elisabetta.abruzzese@uniroma2.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA
- Principal Investigator Name
- Maria Cristina Miggiano
- Principal Investigator Email
- mariacristina.miggiano@aulss8.veneto.it
- Contact Person Name
- Maria Cristina Miggiano
- Contact Person Email
- mariacristina.miggiano@aulss8.veneto.it
- Site Name
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli
- Department Name
- DIPARTIMENTO ONCO-EMATOLOGICO E RADIOTERAPICO - UOC EMATOLOGIA
- Principal Investigator Name
- Caterina Alati
- Principal Investigator Email
- caterina.alati@gmail.com
- Contact Person Name
- Caterina Alati
- Contact Person Email
- caterina.alati@gmail.com
- Site Name
- Azienda Ospedaliera Universita Citta Della Salute E Della Scienza Di Torino
- Department Name
- DIPARTIMENTO DI ONCOLOGIA - SC EMATOLOGIA
- Principal Investigator Name
- Giuseppe Lanzarone
- Principal Investigator Email
- glanzarone@cittadellasalute.to.it
- Contact Person Name
- Giuseppe Lanzarone
- Contact Person Email
- glanzarone@cittadellasalute.to.it
- Site Name
- Azienda Ospedaliero Universitario Senese
- Department Name
- DIPARTIMENTO DI SCIENZE MEDICHE, CHIRURGICHE E NEUROSCIENZE
- Principal Investigator Name
- Monica Bocchia
- Principal Investigator Email
- bocchia@unisi.it
- Contact Person Name
- Monica Bocchia
- Contact Person Email
- bocchia@unisi.it
- Site Name
- Azienda Ospedaliera di Cosenza - P.O. ANNUNZIATA
- Department Name
- DIPARTIMENTO ONCOLOGIA - EMATOLOGIA
- Principal Investigator Name
- Eugenio Lucia
- Principal Investigator Email
- eugenio.lucia74@gmail.com
- Contact Person Name
- Eugenio Lucia
- Contact Person Email
- massimogentile@virgilio.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- DIPARTIMENTO DELL'EMERGENZA E DEI TRAPIANTI DI ORGANI (D.E.T.O.)
- Principal Investigator Name
- Immacolata Attolico
- Principal Investigator Email
- imma.attolico@tin.it
- Contact Person Name
- Immacolata Attolico
- Contact Person Email
- imma.attolico@tin.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA - SC EMATOLOGIA
- Principal Investigator Name
- Alessandro Rambaldi
- Principal Investigator Email
- arambaldi@asst-pg23.it
- Contact Person Name
- Alessandro Rambaldi
- Contact Person Email
- arambaldi@asst-pg23.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- DIPARTIMENTO DI MEDICINA CLINICA 1
- Principal Investigator Name
- Elisabetta Calistri
- Principal Investigator Email
- elisabetta.calistri@iov.veneto.it
- Contact Person Name
- Elisabetta Calistri
- Contact Person Email
- elisabetta.calistri@iov.veneto.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) - UOC EMATOLOGIA
- Principal Investigator Name
- Fausto Castagnetti
- Principal Investigator Email
- fausto.castagnetti@unibo.it
- Contact Person Name
- Fausto Castagnetti
- Contact Person Email
- fausto.castagnetti@unibo.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UOC EMATOLOGIA
- Principal Investigator Name
- Fabrizio Pane
- Principal Investigator Email
- fabrizio.pane@unina.it
- Contact Person Name
- Fabrizio Pane
- Contact Person Email
- fabrizio.pane@unina.it
- Site Name
- Ospedale Santa Maria Goretti Latina
- Department Name
- UOC EMATOLOGIA
- Principal Investigator Name
- Alessandro Pulsoni
- Principal Investigator Email
- alessandro.pulsoni@uniroma1.it
- Contact Person Name
- Alessandro Pulsoni
- Contact Person Email
- alessandro.pulsoni@uniroma1.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- UOC ONCOEMATOLOGIA
- Principal Investigator Name
- Filippo Gherlinzoni
- Principal Investigator Email
- filippo.gherlinzoni@aulss2.veneto.it
- Contact Person Name
- Filippo Gherlinzoni
- Contact Person Email
- filippo.gherlinzoni@aulss2.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Di Piacenza
- Department Name
- DIPARTIMENTO ONCOLOGIA - EMATOLOGIA
- Principal Investigator Name
- Daniele Vallisa
- Principal Investigator Email
- d.vallisa@ausl.pc.it
- Contact Person Name
- Daniele Vallisa
- Contact Person Email
- d.vallisa@ausl.pc.it
- Site Name
- Ospedale Di Sassuolo S.p.A.
- Department Name
- DAY HOSPITAL ONCOLOGICO
- Principal Investigator Name
- Sara Bigliardi
- Principal Investigator Email
- s.bigliardi@ausl.mo.it
- Contact Person Name
- Sara Bigliardi
- Contact Person Email
- s.bigliardi@ausl.mo.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- DIPARTIMENTO ONCOLOGICO E TECNOLOGIE AVANZATE - UO EMATOLOGIA DAY SERVICE
- Principal Investigator Name
- Isabella Capodanno
- Principal Investigator Email
- isabella.capodanno@ausl.re.it
- Contact Person Name
- Isabella Capodanno
- Contact Person Email
- isabella.capodanno@ausl.re.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- DIMECS E DIPARTIMENTO ONCOLOGICO - SCDU EMATOLOGIA
- Principal Investigator Name
- Monia Lunghi
- Principal Investigator Email
- monia.lunghi@med.unipmn.it
- Contact Person Name
- Monia Lunghi
- Contact Person Email
- monia.lunghi@med.unipmn.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE - UOC EMATOLOGIA
- Principal Investigator Name
- Massimo Breccia
- Principal Investigator Email
- breccia@bce.uniroma1.it
- Contact Person Name
- Massimo Breccia
- Contact Person Email
- breccia@bce.uniroma1.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone
- Department Name
- DIPARTIMENTO BIOMEDICO DI MEDICINA INTERNA E SPECIALISTICA - UO EMATOLOGIA
- Principal Investigator Name
- Sergio Siragusa
- Principal Investigator Email
- sergio.siragusa@unipa.it
- Contact Person Name
- Sergio Siragusa
- Contact Person Email
- sergio.siragusa@unipa.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- DIPARTIMENTO DI EMATOLOGIA ED IMMUNOLOGIA CLINICA - UO EMATOLOGIA
- Principal Investigator Name
- Gianni Binotto
- Principal Investigator Email
- gianni.binotto@unipd.it
- Contact Person Name
- Gianni Binotto
- Contact Person Email
- gianni.binotto@unipd.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- DIPARTIMENTO SCIENZE ONCOLOGICHE - UOC EMATOLOGIA
- Principal Investigator Name
- Agostino Tafuri
- Principal Investigator Email
- agostino.tafuri@ospedalesantandrea.it
- Contact Person Name
- Agostino Tafuri
- Contact Person Email
- agostino.tafuri@ospedalesantandrea.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- SC ONCOLOGIA MEDICA GRUPPO DI PATOLOGIA EMATOLOGIA
- Principal Investigator Name
- Alessandro Lucchesi
- Principal Investigator Email
- a.lucchesi@irst.emr.it
- Contact Person Name
- Alessandro Lucchesi
- Contact Person Email
- a.lucchesi@irst.emr.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE
- Principal Investigator Name
- Carmen Fava
- Principal Investigator Email
- carmen.fava@unito.it
- Contact Person Name
- Carmen Fava
- Contact Person Email
- carmen.fava@unito.it
- Site Name
- P.O. Santa Maria Loreto Nuovo- ASL Napoli 1 Centrale
- Department Name
- UOC DI EMATOLOGIA
- Principal Investigator Name
- Angiolina Rocino
- Principal Investigator Email
- anrocino@gmail.com
- Contact Person Name
- Angiolina Rocino
- Contact Person Email
- anrocino@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
- Principal Investigator Name
- Simona Sica
- Principal Investigator Email
- simona.sica@Unicatt.it
- Contact Person Name
- Simona Sica
- Contact Person Email
- simona.sica@Unicatt.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- DIPARTIMENTO DI MEDICINA INTERNA
- Principal Investigator Name
- Alessandra Iurlo
- Principal Investigator Email
- alessandra.iurlo@policlinico.mi.it
- Contact Person Name
- Alessandra Iurlo
- Contact Person Email
- alessandra.iurlo@policlinico.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, MATERNO-INFANTILI DELL'ADULTO - SC EMATOLOGIA
- Principal Investigator Name
- Roberto Marasca
- Principal Investigator Email
- roberto.marasca@unimore.it
- Contact Person Name
- Roberto Marasca
- Contact Person Email
- roberto.marasca@unimore.it
- Site Name
- Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- DIPARTIMENTO DI ONCOLOGIA - SC EMATOLOGIA
- Principal Investigator Name
- Giuseppe Lanzarone
- Principal Investigator Email
- glanzarone@cittadellasalute.to.it
- Contact Person Name
- Giuseppe Lanzarone
- Contact Person Email
- glanzarone@cittadellasalute.to.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
- Department Name
- DIPARTIMENTO INTERNISTICO E DI EMERGENZA-URGENZA E ACCETTAZIONE STRUTTURALE
- Principal Investigator Name
- Monia Marchetti
- Principal Investigator Email
- monia.marchetti@ospedale.al.it
- Contact Person Name
- Monia Marchetti
- Contact Person Email
- monia.marchetti@ospedale.al.it
- Site Name
- Azienda Ospedaliero Universitaria Di Sassari
- Department Name
- DIPARTIMENTO DI MEDICINA CLINICA E SPERIMENTALE - UOC EMATOLOGIA
- Principal Investigator Name
- Claudio Fozza
- Principal Investigator Email
- cfozza@uniss.it
- Contact Person Name
- Claudio Fozza
- Contact Person Email
- cfozza@uniss.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) - UOC EMATOLOGIA
- Principal Investigator Name
- Fausto Castagnetti
- Principal Investigator Email
- fausto.castagnetti@unibo.it
- Contact Person Name
- Fausto Castagnetti
- Contact Person Email
- fausto.castagnetti@unibo.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) - UOC EMATOLOGIA
- Principal Investigator Name
- Fausto Castagnetti
- Principal Investigator Email
- fausto.castagnetti@unibo.it
- Contact Person Name
- Fausto Castagnetti
- Contact Person Email
- fausto.castagnetti@unibo.it
Sponsor
Primary sponsor
- Full Name
- Fondazione Gimema Franco Mandelli Onlus
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Italy
Third parties
- {"country":"Netherlands","full_name":"Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting","duties_or_roles":"sponsor duties code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Italy","full_name":"Laboratorio Centro Clinico Unità Operativa di Ematologia","duties_or_roles":"sponsor duties code 4","organisation_type":"Health care"}
- {"country":"Italy","full_name":"Laboratorio di Ematologia- UOC Ematologia-Policlinico S.M. Scotte","duties_or_roles":"sponsor duties code 4","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Glivec 100 mg hard capsules
- Active Substance
- Imatinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation referenced)
- Maximum Dose
- 400 mg per day
- Investigational Product Name
- Tasigna 150 mg hard capsules
- Active Substance
- Nilotinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation referenced)
- Maximum Dose
- 600 mg per day
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