Clinical trial • Phase II • Oncology|Haematology
Ponatinib for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
Phase II trial of Ponatinib for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). None/Not specified-controlled. 67 participants.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-08-2024
- First CTIS Authorization Date
- 18-09-2024
Trial design
None/Not specified-controlled Phase II trial across 51 sites in Italy.
- Comparator
- None/Not specified
- Target Sample Size
- 67
- Trial Duration For Participant
- 730
Eligibility
Recruits 67 Vulnerable population selected. Signed written informed consent according to ICH/EU/GCP and national local laws is required. Participants must be >=18 years (no pediatric enrolment). No assent or proxy consent procedures are described in the available criteria..
- Pregnancy Exclusion
- For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
- Vulnerable Population
- Vulnerable population selected. Signed written informed consent according to ICH/EU/GCP and national local laws is required. Participants must be >=18 years (no pediatric enrolment). No assent or proxy consent procedures are described in the available criteria.
Inclusion criteria
- {"criterion_text":"- Ph+ ALL patients with evidence of MRD disease or in hematologic and extra-hematologic relapse/refractoriness after any previous treatment, will be considered eligible to enter the study.\n- Age =18 years old with no upper age limit.\n- Adequate hepatic function as defined by the following criteria:- total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome- alanine aminotransferase (ALT) =2.5 × ULN- aspartate aminotransferase (AST) =2.5 × ULN.\n- Adequate pancreatic function as defined by the following criterion: - serum lipase and amylase =1.5 × ULN.\n- For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.\n- Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.\n- Signed written informed consent according to ICH/EU/GCP and national local laws."}
Exclusion criteria
- {"criterion_text":"- WHO performance status = 50% (Karnofsky) or = 3 (ECOG).\n- Uncontrolled active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN not due to the disease.\n- History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.\n- History of alcohol abuse.\n- Ongoing or active uncontrolled infections.\n- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).\n- Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to:- any history of myocardial infarction, stroke, or revascularization- unstable angina or transient ischemic attack within 6 months prior to enrollment- congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment- history of clinically significant (as determined by the treating physician) atrial arrhythmia- any history of ventricular arrhythmia- any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism- uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.\n- Taking medications that are known to be associated with Torsades de Pointes.\n- Taking any 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- Patients who are currently receiving treatment with any of the medications listed in Appendix E if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the rate of patients who achieve a MRD negativity/MRD reduction following treatment with either Ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment.","definition_or_measurement_approach":"MRD negativity / MRD reduction assessed after 3 months of treatment; primary objective will be analyzed separately in two groups (MRD+ patients and hematologically/extra-hematologically relapsed/refractory patients)."}
Secondary endpoints
- {"endpoint_text":"- Duration of CMR, if applicable.","definition_or_measurement_approach":"Duration of complete molecular remission (CMR) measured from achievement to loss of CMR."}
- {"endpoint_text":"- Rate of patients who achieve an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease.","definition_or_measurement_approach":"Rate of hematologic remissions in the subgroup treated for hematologic/extra-hematologic relapse or refractory disease."}
- {"endpoint_text":"- The best molecular response achieved during the study.","definition_or_measurement_approach":"Assessment of best molecular response at any time during study treatment."}
- {"endpoint_text":"- Safety profile in terms of incidence of grade >3 CTC-NCI side effects and toxicities (AE/SAEs).","definition_or_measurement_approach":"Incidence of adverse events and serious adverse events graded by CTC-NCI; focus on grade >3 events."}
- {"endpoint_text":"- Mutational analysis in terms of occurrence, type and number of BCR-ABL1 kinase domain mutations.","definition_or_measurement_approach":"Genetic analysis to detect occurrence, type and number of BCR-ABL1 kinase domain mutations."}
- {"endpoint_text":"- Correlation between the achievement and duration of CMR (or MRD reduction) with the type of fusion protein (e.g. p190 or p210) and the potential occurrence of mutations, as well as with additional genomic lesions","definition_or_measurement_approach":"Correlation analyses between MRD/CMR outcomes and type of BCR-ABL fusion protein (p190 vs p210), mutation status and additional genomic lesions."}
- {"endpoint_text":"- DFS at 24 months.","definition_or_measurement_approach":"Disease-free survival assessed at 24 months."}
- {"endpoint_text":"- OS at 24 months","definition_or_measurement_approach":"Overall survival assessed at 24 months."}
- {"endpoint_text":"- CIR at 24 months.","definition_or_measurement_approach":"Cumulative incidence of relapse assessed at 24 months."}
- {"endpoint_text":"- Role of clinical and biological assessment at baseline, type of fusion protein (p190 vs p210) and presence of additional genomic lesions and mutations, duration on CMR, OS and DFS.","definition_or_measurement_approach":"Exploratory analyses of baseline clinical/biological parameters, fusion protein type and genomic lesions in relation to duration of CMR, OS and DFS."}
Recruitment
- Planned Sample Size
- 67
- Recruitment Window Months
- 65
- Consent Approach
- Signed written informed consent according to ICH/EU/GCP and national local laws is required. Subject information and informed consent form documents are listed (L1 and L2). Participants are adults (>=18); no assent or proxy consent described; languages of documents not specified.
Geography
- Total Number Of Sites
- 51
- Total Number Of Participants
- 67
Italy
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 18-09-2024
- Processing Time Days
- 48
- Number Of Sites
- 51
- Number Of Participants
- 67
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- DIPARTIMENTO DI CHIRURGIA GENERALE E SPECIALITA' MEDICO CHIRURGICHE
- Principal Investigator Name
- Francesco Di Raimondo
- Principal Investigator Email
- diraimon@unict.it
- Contact Person Name
- Francesco Di Raimondo
- Contact Person Email
- diraimon@unict.it
- Site Name
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Department Name
- DIPARTIMENTO DELL'EMERGENZA E DEI TRAPIANTI DI ORGANI (D.E.T.O.)
- Principal Investigator Name
- Pellegrino Musto
- Principal Investigator Email
- pellegrino.musto@uniba.it
- Contact Person Name
- Pellegrino Musto
- Contact Person Email
- pellegrino.musto@uniba.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
- Department Name
- DIPARTIMENTO DI MEDICINA INTERNA
- Principal Investigator Name
- Attilio Olivieri
- Principal Investigator Email
- a.olivieri@univpm.it
- Contact Person Name
- Attilio Olivieri
- Contact Person Email
- a.olivieri@univpm.it
- Site Name
- AORN San Giuseppe Moscati Avellino
- Department Name
- DIPARTIMENTO ONCO-EMATOLOGICO
- Principal Investigator Name
- Lidia Santoro
- Principal Investigator Email
- lidiasantoro63@libero.it
- Contact Person Name
- Lidia Santoro
- Contact Person Email
- lidiasantoro63@libero.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- DIPARTIMENTO DI ONCOLOGIA ED 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
- 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)
- Principal Investigator Name
- Cristina Papayannidis
- Principal Investigator Email
- cristina.papayannidis@unibo.it
- Contact Person Name
- Cristina Papayannidis
- Contact Person Email
- cristina.papayannidis@unibo.it
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- DIPARTIMENTO DI ONCO-EMATOLOGIA
- Principal Investigator Name
- Mariachiara Abbenante
- Principal Investigator Email
- m.abbenante@operapadrepio.it
- Contact Person Name
- Mariachiara Abbenante
- Contact Person Email
- m.abbenante@operapadrepio.it
- Site Name
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli
- Department Name
- DIPARTIMENTO ONCO-EMATOLOGICO E RADIOTERAPICO
- 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
- Ospedale S. Eugenio, ASL Roma 2
- Department Name
- DIPARTIMENTO DELLE SPECIALITÀ
- Principal Investigator Name
- Paolo De Fabritiis
- Principal Investigator Email
- paolo.de.fabritiis@uniroma2.it
- Contact Person Name
- Paolo De Fabritiis
- Contact Person Email
- paolo.de.fabritiis@uniroma2.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE
- Principal Investigator Name
- Sabina Chiaretti
- Principal Investigator Email
- chiaretti@bce.uniroma1.it
- Contact Person Name
- Sabina Chiaretti
- Contact Person Email
- chiaretti@bce.uniroma1.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
- Principal Investigator Name
- Federica Sorà
- Principal Investigator Email
- federica.sora@Unicatt.it
- Contact Person Name
- Federica Sorà
- Contact Person Email
- federica.sora@Unicatt.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA
- Principal Investigator Name
- Stefano D'Ardia
- Principal Investigator Email
- sdardia@cittadellasalute.to.it
- Contact Person Name
- Stefano D'Ardia
- Contact Person Email
- sdardia@cittadellasalute.to.it
- Site Name
- Azienda Ospedaliero Universitaria Ospedali Riuniti
- Department Name
- DIPARTIMENTO ONCO-EMATOLOGICO
- Principal Investigator Name
- Lorella Melillo
- Principal Investigator Email
- lmelillo@ospedaliriunitifoggia.it
- Contact Person Name
- Lorella Melillo
- Contact Person Email
- lmelillo@ospedaliriunitifoggia.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- DIPARTIMENTO MEDICINA GENERALE E SPECIALISTICO
- Principal Investigator Name
- Benedetta Cambò
- Principal Investigator Email
- bcambo@ao.pr.it
- Contact Person Name
- Benedetta Cambò
- Contact Person Email
- bcambo@ao.pr.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- 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 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
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- DIPARTIMENTO ONCOLOGIA
- Principal Investigator Name
- Patrizia Zappasodi
- Principal Investigator Email
- p.zappasodi@smatteo.pv.it
- Contact Person Name
- Patrizia Zappasodi
- Contact Person Email
- p.zappasodi@smatteo.pv.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- DIPARTIMENTO ONCOEMATOLOGICO
- Principal Investigator Name
- Michela Rondoni
- Principal Investigator Email
- michela.rondoni@auslromagna.it
- Contact Person Name
- Michela Rondoni
- Contact Person Email
- michela.rondoni@auslromagna.it
- Site Name
- ULSS3 SERENISSIMA - Ospedale dell'Angelo di Mestre
- Department Name
- UO EMATOLOGIA
- Principal Investigator Name
- Cristina Skert
- Principal Investigator Email
- cristina.skert@aulss3.veneto.it
- Contact Person Name
- Cristina Skert
- Contact Person Email
- cristina.skert@aulss3.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- DIPARTIMENTO ONCOEMATOLOGICO
- Principal Investigator Name
- Anna Maria Mianulli
- Principal Investigator Email
- annamariamianulli@libero.it
- Contact Person Name
- Anna Maria Mianulli
- Contact Person Email
- annamariamianulli@libero.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
- Ospedale Vito Fazzi Lecce
- Department Name
- POLO ONCOLOGICO “GIOVANNI PAOLO II”
- 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 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
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- DIPARTIMENTO ONCO EMATOLOGICO
- Principal Investigator Name
- Carmine Selleri
- Principal Investigator Email
- cselleri@unisa.it
- Contact Person Name
- Carmine Selleri
- Contact Person Email
- cselleri@unisa.it
- Site Name
- ASL DELLA PROVINCIA DI BARLETTA, ANDRIA, TRANI, OSPEDALE "MONS. DIMICCOLI" - BARLETTA
- Department Name
- UO EMATOLOGIA
- Principal Investigator Name
- Giuseppe Tarantini
- Principal Investigator Email
- Giuseppe.Tarantini@aslbat.it
- Contact Person Name
- Giuseppe Tarantini
- Contact Person Email
- Giuseppe.Tarantini@aslbat.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE
- Principal Investigator Name
- Alessandro Cignetti
- Principal Investigator Email
- alessandro.cignetti@unito.it
- Contact Person Name
- Alessandro Cignetti
- Contact Person Email
- alessandro.cignetti@unito.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- DIPARTIMENTO DI MEDICINA
- Principal Investigator Name
- Maria Ilaria Del Principe
- Principal Investigator Email
- del.principe@med.uniroma2.it
- Contact Person Name
- Maria Ilaria Del Principe
- Contact Person Email
- del.principe@med.uniroma2.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA
- 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
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA
- Principal Investigator Name
- Valentina Mancini
- Principal Investigator Email
- valentina.mancini@ospedaleniguarda.it
- Contact Person Name
- Valentina Mancini
- Contact Person Email
- valentina.mancini@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
- Department Name
- DIPARTIMENTO DI ONCOLOGIA
- Principal Investigator Name
- Antonio Mulè
- Principal Investigator Email
- a.mule@villasofia.it
- Contact Person Name
- Antonio Mulè
- Contact Person Email
- a.mule@villasofia.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
- Careggi University Hospital
- Department Name
- DIPARTIMENTO DI MEDICINA SPERIMENTALE E CLINICA
- Principal Investigator Name
- Barbara Scappini
- Principal Investigator Email
- scappinib@aou-careggi.toscana.it
- Contact Person Name
- Barbara Scappini
- Contact Person Email
- scappinib@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- DIPARTIMENTO DI ONCOLOGIA
- Principal Investigator Name
- Luisa Giaccone
- Principal Investigator Email
- luisa.giaccone@unito.it
- Contact Person Name
- Luisa Giaccone
- Contact Person Email
- luisa.giaccone@unito.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA
- Principal Investigator Name
- Corinna Greco
- Principal Investigator Email
- corinna.greco@aulss8.veneto.it
- Contact Person Name
- Corinna Greco
- Contact Person Email
- corinna.greco@aulss8.veneto.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- DIPARTIMENTO TERAPIE ONCOLOGICHE INTEGRATE
- Principal Investigator Name
- Germana Beltrami
- Principal Investigator Email
- germana.beltrami@hsanmartino.it
- Contact Person Name
- Germana Beltrami
- Contact Person Email
- germana.beltrami@hsanmartino.it
- Site Name
- Azienda Sanitaria Territoriale Di Ascoli Piceno
- Department Name
- UOC EMATOLOGIA
- Principal Investigator Name
- Piero Galieni
- Principal Investigator Email
- piero.galieni@sanita.marche.it
- Contact Person Name
- Piero Galieni
- Contact Person Email
- piero.galieni@sanita.marche.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- AREA MEDICINA ONCOLOGICA
- Principal Investigator Name
- Atelda Romano
- Principal Investigator Email
- atelda.romano@ifo.it
- Contact Person Name
- Atelda Romano
- Contact Person Email
- atelda.romano@ifo.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- DIMECS E DIPARTIMENTO ONCOLOGICO
- 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 Ospedaliera Universitaria Gaetano Martino Messina
- Department Name
- DIPARTIMENTO DI PATOLOGIA UMANA DELL'ADULTO E DELL'ETÀ EVOLUTIVA
- Principal Investigator Name
- Alessndro Allegra
- Principal Investigator Email
- aallegra@unime.it
- Contact Person Name
- Alessndro Allegra
- Contact Person Email
- aallegra@unime.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- DIPARTIMENTO DI EMATOLOGIA ED IMMUNOLOGIA CLINICA
- Principal Investigator Name
- Silvia Imbergamo
- Principal Investigator Email
- silvia.imbergamo@aopd.veneto.it
- Contact Person Name
- Silvia Imbergamo
- Contact Person Email
- silvia.imbergamo@aopd.veneto.it
- Site Name
- Azienda Sanitaria Locale Di Salerno
- Department Name
- EMATOLOGIA
- Principal Investigator Name
- Catello Califano
- Principal Investigator Email
- c.califano@aslsalerno.it
- Contact Person Name
- Catello Califano
- Contact Person Email
- c.califano@aslsalerno.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- DIPARTIMENTO SCIENZE ONCOLOGICHE
- 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
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Department Name
- DIVISIONE DI EMATOLOGIA DI MURAGLIA
- Principal Investigator Name
- Giuseppe Visani
- Principal Investigator Email
- Giuseppe.visani@sanita.marche.it
- Contact Person Name
- Giuseppe Visani
- Contact Person Email
- Giuseppe.visani@sanita.marche.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- DIPARTIMENTO DI MEDICINA E CHIRURGIA
- Principal Investigator Name
- Maria Paola Martelli
- Principal Investigator Email
- maria.martelli@unipg.it
- 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
- Principal Investigator Name
- Antonio Spadano
- Principal Investigator Email
- tonino.spadano@virgilio.it
- Contact Person Name
- Antonio Spadano
- Contact Person Email
- tonino.spadano@virgilio.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- DIPARTIMENTO DI ONCOLOGIA CLINICA
- Principal Investigator Name
- Erika Borlenghi
- Principal Investigator Email
- erika.borlenghi@gmail.com
- Contact Person Name
- Erika Borlenghi
- Contact Person Email
- erika.borlenghi@gmail.com
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- AREA ONCOLOGICA
- Principal Investigator Name
- Fabio Ciceri
- Principal Investigator Email
- ciceri.clinicaltrials@hsr.it
- Contact Person Name
- Fabio Ciceri
- Contact Person Email
- ciceri.clinicaltrials@hsr.it
- Site Name
- Azienda Ospedaliera Universitaria 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 Santa Croce E Carle
- Department Name
- SC EMATOLOGIA
- Principal Investigator Name
- Daniele Mattei
- Principal Investigator Email
- mattei.d@ospedale.cuneo.it
- Contact Person Name
- Daniele Mattei
- Contact Person Email
- mattei.d@ospedale.cuneo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- DIPARTIMENTO DI MEDICINA INTERNA
- Principal Investigator Name
- Nicola Fracchiolla
- Principal Investigator Email
- ns.fracchiolla@gmail.com
- Contact Person Name
- Nicola Fracchiolla
- Contact Person Email
- ns.fracchiolla@gmail.com
- Site Name
- Azienda Sanitaria Locale Br
- Department Name
- UO EMATOLOGIA
- Principal Investigator Name
- Domenico Pastore
- Principal Investigator Email
- domenico.pastore0@gmail.com
- Contact Person Name
- Domenico Pastore
- Contact Person Email
- domenico.pastore0@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fondazione Gimema Franco Mandelli Onlus
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Italy
Third parties
- {"country":"Italy","full_name":"Azienda Ospedaliero-Universitaria Policlinico Umberto I","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
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
- Marketing authorisation (EU/1/13/839/001)
- Maximum Dose
- 45 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- Olverembatinib for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
- ponatinib for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
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- RITUXIMAB for Diffuse large B-cell lymphoma (ABC)