Post Marketing Surveillance of Jakavi4 (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease in Korea

What this Trial Is About

Researchers are observing the safety and effectiveness of Jakavi4 (ruxolitinib) in Korean patients with steroid-refractory Graft-versus-Host Disease (GvHD) in a real-world clinical setting. This is a prospective, open-label, multi-center, non-comparative observational study designed to gather data on how the drug performs outside of controlled trial environments. The study is sponsored by Novartis Pharmaceuticals and includes patients who are either newly starting or already taking Jakavi4. Participants will receive Jakavi4 treatment according to the locally approved label, with dosage and duration decided by their investigator. The study includes a 24-week follow-up period to monitor the safety and sustained effectiveness of the treatment. Additional safety monitoring will occur after the last dose to assess any adverse events. There is no treatment allocation or placebo; the study simply observes patients receiving Jakavi4 as part of routine care. During the study, researchers will collect safety data including adverse events and serious adverse events up to 24 weeks after starting treatment. Effectiveness will be evaluated by overall response rates and treatment failure rates at weeks 4 and 24. Blood tests such as complete blood counts will be monitored from baseline to week 24. Participants will provide written consent and undergo follow-up assessments during the study period, which runs until May 2026.

A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea