22
Participants
Start Date
November 30, 2011
Primary Completion Date
February 28, 2015
Study Completion Date
March 31, 2016
nilotinib
Maximum tolerated dosage (MTD) will be defined in Phase I. First 3 patients (pts) will receive Nilotinib 200mg daily dose. If no dose limiting toxicities after at least 1month the next 3 pts will be treated with 300mg. If are\>=2 dose limiting toxicities the Phase I will end and MTD will be defined as the next lower dosage. If they will observe 1dose limiting toxicities, they will treat other 3 pts (same dosage); if there isn't dose limiting toxicity, they will increase the dosage in the next cohort; but if they will observe another dose limiting toxicity (tot limiting toxicities 2/6 pts), the study will continue using the previous dose. MTD will be considered the maximum dosage used to treat 6 pts achieving at most 1 dose limiting toxicities, or the previous dosage if with this dosage they we will achieve 2 dose limiting toxicities. Doses will not be escalated beyond \>600 or \<200mg/die The MTD will be used for phase II
Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo
Chaim Sheba Medical Center, Tel Litwinsky
Clinica di Ematologia - Ospedali Riuniti di Ancona, Ancona
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle, Cuneo
Trapianti Midollo Osseo - Div. di Ematologia 2 - Ospedale S. Martino, Genova
Ospedale Panico, Lecce
Divisione di Ematologia - Istituto Nazionale dei Tumori, Milan
Ospedale Niguarda Ca' Grande, Milan
U.O. Ematologia I - Centro Trapianti di Midollo - Ospedale Maggiore - Policlinico Mangiagalli e Regina Elena, Milan
Ospedale San Carlo, Potenza
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli, Reggio Calabria
Clinica Ematologica - AOU Santa Maria Della Misericordia, Udine
Gruppo Italiano Trapianto di Midollo Osseo
OTHER