Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

February 28, 2015

Study Completion Date

March 31, 2016

Conditions
Chronic Graft Versus Host Disease
Interventions
DRUG

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

Trial Locations (12)

71013

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

Unknown

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

All Listed Sponsors
lead

Gruppo Italiano Trapianto di Midollo Osseo

OTHER

NCT01810718 - Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD | Biotech Hunter | Biotech Hunter