Phase 2 Study of Ruxolitinib for Symptom Relief in Low-Risk Essential Thrombocythemia and Polycythemia Vera

What this Trial Is About

Researchers are evaluating the drug ruxolitinib in people with low-risk but symptomatic essential thrombocythemia ET and polycythemia vera PV. This phase II clinical trial aims to see if ruxolitinib can reduce the symptoms caused by these blood conditions. The study is supported by a biopharmaceutical company and involves patients diagnosed according to specific medical criteria and who have significant symptoms. Participants will receive ruxolitinib pills taken twice daily in 28-day treatment cycles. The trial includes two stages in the first stage, participants receive six cycles of ruxolitinib, and if at least three participants respond positively, the second stage will proceed with similar treatment. Those benefiting from the drug may continue treatment as long as side effects or disease progression do not occur. During the study, participants will undergo screening, evaluations, and follow-up visits. Researchers will measure symptom changes using the Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score over 12 weeks as the primary outcome. Other assessments include blood counts, spleen volume, and monitoring of treatment-related side effects. The total study duration and ongoing monitoring may extend up to 60 months.

Ruxolitinib in Thrombocythemia and Polycythemia Vera