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class="post-1218 otw_pm_portfolio type-otw_pm_portfolio status-publish has-post-thumbnail hentry otw_pm_portfolio_category-leucemia-mieloide-cronica otw_pm_portfolio_category-malattie-mieloproliferative otw_pm_portfolio_tag-leucemia-mieloide-cronica otw_pm_portfolio_tag-sindromi-mieloproliferative">

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