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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 – Rete Ematologica Lombarda

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Project Description

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

Project Details