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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
279
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Incidence and severity of AEs and SAEs
The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades).
Time frame: 12 years
Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.
The analysis of clinical benefit will be descriptive only and cannot be compared to efficacy results of other studies. In addition, as clinical benefit was only added in protocol amendment 1, it may not be available for all participants.
Time frame: 12 years
Incidence and severity of AEs and SAEs by treatment group
AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)
Time frame: 12 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Wooloongabba, Queensland, Australia
Novartis Investigative Site
Bedford Park, South Australia, Australia
Novartis Investigative Site
Box Hill, Victoria, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Franston, Victoria, Australia
Novartis Investigative Site
Perth, Western Australia, Australia
Novartis Investigative Site
St Leonards, Australia
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium
...and 87 more locations