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Phase-III randomized study to Optimize TKIs Multiple Approaches – (OPTkIMA) – and quality of life (QoL) in elderly patients (≥60 years) with Ph+ chronic myeloid leukemia (CML) and MR3.0 / MR4.0 stable molecular response


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Patologia Leucemia Mieloide Cronica
Sponsor Spedali Civili di Brescia
Farmaco Imatinib, Nilotinib, Dasatinib
Fase
Linea seconda

 

Codice studio OPTkIMA 1013
Obiettivo primario Verificare se una somministrazione intermittente di TKI “progressive” (braccio sperimentale) possa fornire risultati migliori in termini di qualità della vita (HRQOL) rispetto a una somministrazione intermittente di TKI “fixed” (braccio di controllo).

 

Responsabile della sperimentazione Prof. Fabio Ciceri, Ospedale San Raffaele Milano
Medici referenti Dr.ssa Francesca Lunghi – Ospedale San Raffaele Milano

 

Data inizio dello studio 26 maggio 2017
Durata dello studio Data fine arruolamento prevista: giugno 2018
Stato del protocollo APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof. Fabio Ciceri,

ciceri.clinicaltrials@hsr.it telefono: 0226434289


SCARICA LA SINOSSI DELLO STUDIO
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Registro Rete Ematologica Lombarda delle Sindromi Mielodisplastiche primitive, Leucemie acute e Sindromi Mielodiplastiche secondarie e Neoplasie Mielodisplastiche/Mieloproliferative


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Patologia AML / MDS
Sponsor Promotore Rete Ematologica Lombarda (REL)
Farmaco N.A.
Fase N.A.
Linea prima

 

Codice studio Registro REL-MDS
Obiettivo primario Valutare l’incidenza di Sindromi Mielodisplastiche primitive, LAM/Sindromi Mielodisplastiche secondarie, Neoplasie Mielodisplastiche/Mieloproliferative, descriverne la principali caratteristiche cliniche patologiche e metterle in relazione con eventuali fattori di rischio;

 

Responsabile della sperimentazione Prof. Fabio Ciceri, Ospedale San Raffaele Milano
Medici referenti Dr. Matteo Carrabba – Ospedale San Raffaele Milano

 

Data inizio dello studio 6/12/2011
Durata dello studio non e` previsto il termine dello studio.
Stato del protocollo APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof. Fabio Ciceri,

ciceri.clinicaltrials@hsr.it telefono: 0226434289


SCARICA LA SINOSSI DELLO STUDIO
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Bosutinib efficacy safety tolerability (BEST) study in elderly chronic myeloid leukemia patients failing front-line treatment with other tyrosine kinase inhibitors


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Patologia leucemia mieloide cronica
Sponsor Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto)
Farmaco BOSUTINIB
Fase 2
Linea prima

 

Codice studio BEST CML1516
Obiettivo primario L’obiettivo primario dello studio è quello di valutare l’attività del trattamento di seconda linea con Bosutinib con un aggiustamento della dose in caso di risposta insoddisfacente o tossicità in pazienti anziani affetti da CML in fase cronica (CP) Ph+/BCR-ABL1+, per i quali sia fallito (per resistenza o intolleranza) il trattamento di prima linea con un altro TKI. L’endpoint primario è la proporzione di pazienti che a 52 settimane (1 anno) raggiungono la MMR (BCR-ABL < 0.1% della Scala Internazionale)

 

Responsabile della sperimentazione Prof. Fabio Ciceri, Ospedale San Raffaele Milano
Medici referenti Dr.ssa Francesca Lunghi – Ospedale San Raffaele Milano

 

Data inizio dello studio 15/11/2016
Durata dello studio Data fine arruolamento prevista: 30/10/2018
Stato del protocollo APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof. Fabio Ciceri,

ciceri.clinicaltrials@hsr.it telefono: 0226434289


SCARICA LA SINOSSI DELLO STUDIO
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Optimizing Ponatinib USe (OPUS). A GIMEMA phase 2 study of the activity and risk profile of ponatinib, 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to imatinib


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Patologia leucemia mieloide cronica
Sponsor Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto)
Farmaco Ponatinib
Fase 2
Linea seconda linea

 

Codice studio OPUS CML1315
Obiettivo primario L’obiettivo primario dello studio è valutare l’attività del Ponatinib in seconda linea in pazienti con LMC in fase cronica resistenti all’Imatinib tramite la risposta citogenetica maggiore (MCyR) alla 52 settimana (14 mesi).

 

Responsabile della sperimentazione Prof. Fabio Ciceri, Ospedale San Raffaele Milano
Medici referenti Dr.ssa Francesca Lunghi – Ospedale San Raffaele Milano

 

Data inizio dello studio 21 marzo 2016
Durata dello studio Data fine arruolamento prevista: novembre 2017
Stato del protocollo APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof. Fabio Ciceri,

ciceri.clinicaltrials@hsr.it telefono: 0226434289


SCARICA LA SINOSSI DELLO STUDIO
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OPTIMIZING PONATINIB USE (OPUS). STUDIO GIMEMA DI FASE 2 SULL’EFFICACIA E SUL PROFILO DI RISCHIO DI PONATINIB, 30 MG AL GIORNO, IN PAZIENTI CON LEUCEMIA MIELOIDE CRONICA (LMC) IN FASE CRONICA, RESISTENTI ALL’IMATINIB. Codice Studio: CML1315


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Patologia leucemia mieloide cronica
Sponsor Fondazione GIMENA
Farmaco PONATINIB
Fase 2
Linea seconda

 

Codice studio GIMENA CML1315
EudraCT number 2015-001102-34
Clinical Trial Number NCT02398825
Obiettivo primario Obiettivo primario: valutare l’attività del Ponatinib in seconda linea in pazienti con LMC in fase cronica resistenti all’Imatinib.

 

Responsabile della sperimentazione Dr.ssa Ester M. Orlandi
Fondazione IRCCS Policlinico San Matteo, Pavia
Medici referenti Dr.ssa Ester M. Orlandi, Dr.ssa Chiara Elena
Fondazione IRCCS Policlinico San Matteo, Pavia

 

Data inizio dello studio 25 ottobre 2016
Durata dello studio 5 anni
Stato del protocollo Arruolamento: APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Dr.ssa Ester M.Orlandi    e.orlandi@smatteo.pv.it
Dr.ssa Chiara Elena          c.elena@smatteo.pv.it

SCARICA LA SINOSSI DELLO STUDIO
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STUDIO DI EFFICACIA, SICUREZZA E TOLLERABILITÀ DI BOSUTINIB (BEST) IN PAZIENTI ANZIANI AFFETTI DA LEUCEMIA MIELOIDE CRONICA RESISTENTI AL TRATTAMENTO DI PRIMA LINEA CON ALTRI FARMACI INIBITORI DELLA TIROSIN-CHINASI. Codice Studio: CML1516


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Patologia leucemia mieloide cronica
Sponsor Fondazione GIMENA
Farmaco BOSUTINIB
Fase 2
Linea seconda

 

Codice studio GIMENA CML1516
EudraCT number 2016-002216-40
Clinical Trial Number NCT02810990
Obiettivo primario Obiettivo primario: valutare l’attività del trattamento di seconda linea con Bosutinib con un aggiustamento della dose in caso di risposta insoddisfacente o tossicità in pazienti anziani affetti da CML in fase cronica, per i quali sia fallito (per resistenza o intolleranza) il trattamento di prima linea con un altro TKI.

 

Responsabile della sperimentazione Dr.ssa Ester M. Orlandi
Fondazione IRCCS Policlinico San Matteo, Pavia
Medici referenti Dr.ssa Ester M. Orlandi, Dr.ssa Chiara Elena
Fondazione IRCCS Policlinico San Matteo, Pavia

 

Data inizio dello studio In attesa di determina dalla Direzione Generale
Durata dello studio 5 anni
Stato del protocollo Arruolamento: APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Dr.ssa Ester M.Orlandi    e.orlandi@smatteo.pv.it
Dr.ssa Chiara Elena          c.elena@smatteo.pv.it

SCARICA LA SINOSSI DELLO STUDIO
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STUDIO RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO VERSUS PLACEBO, MULTICENTRICO, DI FASE III, DI VALUTAZIONE DELL’EFFICACIA E DELLA SICUREZZA D’IMPIEGO DI RUXOLITINIB NEI PAZIENTI CON MIELOFIBROSI IN FASE PRECOCE CON MUTAZIONI AD ELEVATO RISCHIO MOLECOLARE. Codice Studio: CINC424A2353


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Patologia mielofibrosi
Sponsor Novartis
Farmaco Ruxolitinib
Fase 3
Linea

 

Codice studio CINC424A2353
Obiettivo primario Valutare l’effetto di Ruxolitinib, nel ritardare la progressione di malattia mielofibrotica.

 

Responsabile della sperimentazione Prof. Francesco Passamonti
ASST dei Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Medici referenti Dr.ssa Domenica Caramazza, Dr.ssa Margherita Maffioli, Dr.ssa Barbara Mora

 

Data inizio dello studio Settembre 2016
Durata dello studio 6 anni
Stato del protocollo Arruolamento APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof.Francesco Passamonti

francesco.passamonti@asst-settelaghi.it

SCARICA LA SINOSSI DELLO STUDIO
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STUDIO IN APERTO, MULTICENTRICO, DI FASE IV PROTOCOLLO ROLL-OVER PER PAZIENTI CHE HANNO COMPLETATO UNO STUDIO PRECEDENTE CON RUXOLITINIB (INC424) PROMOSSO DA NOVARTIS GLOBAL O DA INCYTE E CHE LO SPERIMENTATORE RITIENE PRESENTINO BENEFICIO DAL TRATTAMENTO CONTINUATIVO. Codice Studio: CINC424A2X01B


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Patologia malattia mieloproliferativa
Sponsor Novartis
Farmaco Ruxolitinib
Fase 4
Linea

 

Codice studio CINC424A2X01B
Obiettivo primario Questo studio permette ai pazienti che ricevono monoterapia con Ruxolitinib da altri protocolli sperimentali (novartid global o Incyte) di continuare la terapia sperimentale, qualora ne traggano beneficio.

 

Responsabile della sperimentazione Prof. Francesco Passamonti
ASST dei Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Medici referenti Dr.ssa Domenica Caramazza, Dr.ssa Margherita Maffioli

 

Data inizio dello studio Settembre 2015
Durata dello studio 5 anni
Stato del protocollo Arruolamento APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof.Francesco Passamonti

francesco.passamonti@asst-settelaghi.it

SCARICA LA SINOSSI DELLO STUDIO