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STUDIO DI FASE 3, IN DOPPIO CIECO, RANDOMIZZATO PER CONFRONTARE L’EFFICACIA E LA SICUREZZA DI LUSPATERCEPT (ACE-536) VERSO PLACEBO NEL TRATTAMENTO DELL’ANEMIA DOVUTA A SINDROME MIELODISPLASTICA A RISCHIO IPSS-R MOLTO BASSO, BASSO O INTERMEDIO IN SOGGETTI CON SIDEROBLASTI AD ANELLO CHE NECESSITANO DI TRASFUSIONI DI GLOBULI ROSSI. Codice Studio: ACE-536-MDS-001 – Rete Ematologica Lombarda

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Project Description

Patologia MDS con sideroblasti ad anello
Sponsor Celgene Corporation
Farmaco LUSPATERCEPT (ACE-536)
Fase 3
Linea seconda

 

Codice studio ACE-536-MDS-001
Obiettivo primario Valutare l'indipendenza da trasfusioni di RBC di luspatercept rispetto al placebo per il trattamento dell'anemia dovuta a MDS a rischio molto basso, basso o intermedio secondo IPSS-R in soggetti con sideroblasti ad anello (≥ 15%) che necessitano di trasfusioni di RBC.

 

Responsabile della sperimentazione Prof. Mario Cazzola
Fondazione IRCCS Policlinico San Matteo, Pavia
Medici referenti Prof. Luca Malcovati, Dr. Chiara Elena,
Fondazione IRCCS Policlinico San Matteo Pavia

 

Data inizio dello studio 13 giugno 2016
Durata dello studio 3 anni
Stato del protocollo Arruolamento: APERTO

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Prof. Luca Malcovati
luca.malcovati@unipv.it


Dr. Chiara Elena
c.elena@smatteo.pv.it

SCARICA LA SINOSSI DELLO STUDIO

Project Details