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STUDIO DI FASE 3, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CHE SI PROPONE DI CONFRONTARE L’EFFICACIA E LA SICUREZZA DELL’AZACITIDINA ORALE SOMMINISTRATA INSIEME ALLA MIGLIOR TERAPIA DI SUPPORTO CON IL PLACEBO SOMMINISTRATO INSIEME ALLA MIGLIORE TERAPIA DI SUPPORTO A SOGGETTI CON ANEMIA TRASFUSIONE-DIPENDENTE E TROMBOCITOPENIA CAUSATE DA SINDROMI MIELODISPLASTICHE A PIÙ BASSO RISCHIO SECONDO L’IPSS. Codice Studio: AZA-MDS-003 – Rete Ematologica Lombarda

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Project Description

Patologia MDS
Sponsor Celgene Corporation
Farmaco ORAL AZACITIDINE
Fase 3
Linea prima

 

Codice studio AZA-MDS-003
Obiettivo primario Valutare l'indipendenza da trasfusioni di globuli rossi nei 2 bracci di trattamento (azacitidina orale associata alla migliore terapia di supporto rispetto a placebo associato alla migliore terapia di supporto) nella suddetta popolazione di pazienti.

 

Responsabili della sperimentazione Prof. Luca Malcovati, Fondazione IRCCS Policlinico San Matteo, Pavia
Prof. Matteo Della Porta, Cancer Center - Humanitas Research Hospital, Rozzano, Milano

Medici referenti Prof. Luca Malcovati, Dr.ssa Chiara Elena - Fondazione IRCCS Policlinico San Matteo Pavia
Dr.ssa. Marianna Rossi, Dr.ssa Elisabetta Todisco - Humanitas Research Hospital, Rozzano Milano

 

Data inizio dello studio agosto 2016 (Fondazione IRCCS Policlinico San Matteo, Pavia)
maggio 2017 (Humanitas Research Hospital, Rozzano MI)

Durata dello studio 5 anni (circa)
Stato del protocollo Arruolamento: APERTO (Fondazione IRCCS Policlinico San Matteo, Pavia)
Arruolamento: IN APERTURA (Humanitas Research Hospital, Rozzano MI)

 

Persona da contattare per l’invio di pazienti
e modalità di contatto
Fondazione IRCCS Policlinico San Matteo, Pavia
Prof. Luca Malcovati   luca.malcovati@unipv.it

Humanitas Research Hospital, Rozzano Milano
Prof. Matteo Della Porta   matteo.della_porta@hunimed.eu


SCARICA LA SINOSSI DELLO STUDIO

Project Details