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.

NCT01810718

Conditions

1. Chronic Graft Versus Host Disease

Interventions

1. Drug: nilotinib

MeSH:Graft vs Host Disease

It has to be noticed that in all the proliferation assays the concentration at which 50% of effect is inhibited of Nilotinib is lower than 50 nM, apart from the two BCR-ABL mutants (E255K and E255V) where the IC50 is 600 to 700 nM. --- E255K --- --- E255V ---

Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.

NCT02389920

Conditions

1. Leukemia, Chronic Myeloid

Interventions

1. Drug: Nilotinib

MeSH:Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

HPO:Chronic myelogenous leukemia Leukemia

- Potassium ≥ LLN- Magnesium ≥ LLN- Phosphorus ≥ LLN 7. Voluntary, signed and dated informed consent prior to any study procedures being performed Exclusion Criteria: 1. Subjects with the T315I mutation 2. Mutation known to be associated with low sensitivity to nilotinib(e.g., Y253H, E255K, E255V, F359V), 3. Cardiac function abnormalities as follows are found. --- T315I --- --- Y253H --- --- E255K --- --- E255V ---