Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late
non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a
standard satisfactory treatment for these patients does not exist. cGVHD is an
immune-mediated disease, resulting from a complex interaction between donor and recipient
adaptive immunity, but its exact pathogenesis is still incompletely defined.
The purpose of this study is to determine safety and efficacy of Nilotinib in a population
with steroid-refractory/or steroid-dependent cGvHD with a phase I study.
In phase II the MTD will be used to define the efficacy of Nilotinib in a cGvHD steroid-
refractory or steroid dependent population, with the same characteristics of the previously
Imatinib-treated population.