indications including but not limited to myelofibrosis (MF), polycythemia vera (PV), acute Graft vs Host Disease (aGvHD) or chronic Graft vs Host Disease (cGvHD).
Conditions
Interventions
treatment with ruxolitinib or combination of ruxolitinib and panobinostat
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients who are currently enrolled in a Novartis-sponsored study or Incyte-sponsored study that has reached its study objectives, who are not progressing on the current study treatment as defined by the parent protocol, have completed their obligations in the parent study and are unable to access ruxolitinib or combination of ruxolitinib and panobinostat outside of a clinical study. Patients must be benefiting from treatment as judged by the investigator at the completion of the parent study.
Exclusion criteria
Exclusion criteria: Patient has been permanently discontinued from study treatment in the parent study due to any reason. Patient indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety To evaluate long term safety data i.e. SAEs and AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy To evaluate clinical benefit as assessed by the investigator. | — |
Countries
Africa, Asia except Japan, Europe, Japan, Oceania, South America
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed