NCT02386800

CINC424A2X01B Rollover Protocol

Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Month – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Myelofibrosis
• Polycythemia Vera
• Graft Versus Host Disease
• Acute Myeloid Leukemia
• Thalassemia

Interventions

Type	Name	Description
DRUG	ruxolitinib	ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
DRUG	panobinostat	panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Timeline

• Start date: 2015-03-05
• Primary completion: 2027-09-16
• Completion: 2027-09-16
• First posted: 2015-03-12
• Last updated: 2026-03-16

Locations

97 sites across 25 countries: Australia, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Lebanon, Mexico, Poland, Portugal, Russia, South Africa, South Korea, Spain, Sweden, Thailand, Turkey (Türkiye)