Study Description
This is a long term safety study for patients that have been treated with either
ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte
sponsored study, who have been judged by the study Investigator to benefit from ongoing
treatment. This roll-over protocol allows patients from multiple protocols, who are still receiving
clinical benefit, to continue their treatment in one study that covers multiple
indications. The population for the roll-over study should be consistent with the
population defined in the parent studies. The primary eligibility criteria for a patient
to enter the roll-over protocol is the participation and completion of a Novartis or
Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
Efficacy parameters will not be measured; however safety data and an evaluation of
clinical benefit will be collected.
Interventions
panobinostat
ruxolitinib
Eligibility Criteria
Key Inclusion criteria:
1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored
clinical study, are receiving either ruxolitinib or combination of ruxolitinib and
panobinostat, and fulfilled all of the requirements of the parent protocol.
2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or
combination of ruxolitinib and panobinostat, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the
parent study protocol requirements
4. Patient currently has no evidence of progressive disease, as determined by the
investigator, following previous treatment with ruxolitinib or combination of
ruxolitinib and panobinostat
Key Exclusion criteria:
1. Patient has been permanently discontinued from study treatment in the parent study
due to any reason.
2. Patient's indication is currently approved and reimbursed in the corresponding
country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
3. Pregnant or nursing (lactating) women.
4. Female patients of childbearing potential (e.g. are menstruating) who do not agree
to abstinence or, if sexually active, do not agree to the use of highly effective
contraception, throughout the study and for up to 30 days after stopping study
treatment.
Other protocol-defined Inclusion / Exclusion criteria may apply.
Worldwide Contacts
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