Chronic myeloproliferative neoplasm
Conditions
Brief summary
Long term safety and tolerability • Number of patients experience adverse events • Type, incidence, and severity of treatment-related adverse events, graded according to the latest available version of Common Terminology Criteria for Adverse Events (CTCAE)., Long term efficacy • For PV and ET: Complete response (CR) and partial response (PR) rate according to the revised clinicl-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. Please refer to the protocol for the full details
Detailed description
The effect of givinostat on each single response parameter according to the revised ELN (For PV and ET) and EUMNET response criteria (for MF), Reduction of the JAK2v617F allele burden by quantitative RT-PCR, Identification of potential other markers predictive of clinical benefit of givinostat (e.g. potential PD markers)., Evaluation of the parameters that allows to evaluate the disease evolution and history (e.g. thrombotic rate, PFS etc.).
Interventions
Sponsors
Italfarmaco S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term safety and tolerability • Number of patients experience adverse events • Type, incidence, and severity of treatment-related adverse events, graded according to the latest available version of Common Terminology Criteria for Adverse Events (CTCAE)., Long term efficacy • For PV and ET: Complete response (CR) and partial response (PR) rate according to the revised clinicl-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. Please refer to the protocol for the full details | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of givinostat on each single response parameter according to the revised ELN (For PV and ET) and EUMNET response criteria (for MF), Reduction of the JAK2v617F allele burden by quantitative RT-PCR, Identification of potential other markers predictive of clinical benefit of givinostat (e.g. potential PD markers)., Evaluation of the parameters that allows to evaluate the disease evolution and history (e.g. thrombotic rate, PFS etc.). | — |
Countries
Italy
Outcome results
None listed