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A phase 2, international, multicenter, randomized, open-label, parallel group study to evaluate the efficacy and safety of CC-486 (oral Azacitidine) alone and in combination with Durvalumab (MEDI4736) in subject with myelodysplastic syndromes who fail to achieve an objective response to treatment with Azacitidine for injection or Decitabine – Rete Ematologica Lombarda

A phase 2, international, multicenter, randomized, open-label, parallel group study to evaluate the efficacy and safety of CC-486 (oral Azacitidine) alone and in combination with Durvalumab (MEDI4736) in subject with myelodysplastic syndromes who fail to achieve an objective response to treatment with Azacitidine for injection or Decitabine


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Project Description

Patologia MDS
Sponsor Celgene Corporation
Farmaco CC-486 e MEDI4736
Fase 2
Linea pazienti che non mostrano risposta al precedente trattamento con azacitidina iniettabile o decitabina.
 
Codice studio CC-486-MDS­006
Obiettivo primario L'endpoint primario di questo studio è il tasso complessivo di risposta obiettiva (ORR) al trattamento con CC-486 in monoterapia e con terapia combinata con CC-486 e durvalumab: proporzione di soggetti che raggiungono una risposta obiettiva (miglioramento ematologico [HI], risposta parziale [PR], remissione completa [CR] o CR del midollo) in base ai criteri modificati dell'International Working Group (IWG) 2006.
 
Responsabile della sperimentazione Prof. Fabio Ciceri, Ospedale San Raffaele Milano
Medici referenti Dr. Matteo Carrabba - Ospedale San Raffaele Milano
 
Data inizio dello studio 31 maggio 2017
Durata dello studio Data fine arruolamento prevista: giugno 2019
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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