Long-term Study Evaluating the Effect of Givinostat in Patients With JAK2V617F Positive Chronic Myeloproliferative Neoplasms
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Long-term safety and efficacy
To obtain information on the long-term efficacy of Givinostat in patients with cMPN following core protocols or compassionate use program: Number of patients experiencing adverse events; Type, incidence, and severity of treatment-related adverse events, graded according to CTCAE v. 4.03. To determine the long term safety and tolerability of Givinostat in patients with cMPN following core protocols or compassionate use program: For PV and ET, Complete response (CR) and partial response (PR) rate according to the revised clinico-haematological European LeukemiaNet (ELN) response criteria; For MF, complete response, major response, moderate response and minor response rate according to European Myelofibrosis Network (EUMNET) response criteria. Note that these assessment will be repeated periodically (each 3 months) during the study. In fact, the treatment will continue up to Marketing Authorisation of Givinostat.
Alessandro Rambaldi, MD
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy
Italy: Ethics Committee