Phase IIb Study of Flonoltinib Maleate Tablets for Adults With Intermediate- or High-risk Myelofibrosis Who Did Not Respond or Are Intolerant to JAK Inhibitors

What this Trial Is About

Researchers are evaluating flonoltinib maleate tablets in adult patients with intermediate to high-risk myelofibrosis MF who are refractory, relapsed, or intolerant to JAK inhibitors. This single-arm, open-label, multicenter phase IIb clinical trial aims to assess the safety and efficacy of this treatment in patients who have limited options after prior JAK inhibitor therapy. Participants will receive flonoltinib maleate tablets orally once daily on an empty stomach. The dose, either 50mg or 75mg, is assigned based on platelet counts measured during the screening period. Treatment continues until participants meet withdrawal criteria. The study includes approximately 64 participants and focuses on those with splenomegaly and specific blood count and organ function criteria. During the study, participants will be monitored regularly for spleen volume reduction, symptom improvement using the MPN-SAF TSS score, and overall survival over 24 weeks. Safety and organ function tests, including blood counts and liver and kidney function, will be performed. Researchers will track treatment effects and side effects throughout the trial duration, with all assessments planned at various time points including weeks 2, 4, 8, 12, and 24.

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Medium to High Risk Myelofibrosis