Phase III Study on the Safety and Effectiveness of Flonoltinib Maleate Tablets for Adults with Intermediate- or High-risk Myelofibrosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Flonoltinib Maleate Tablets in adults with intermediate- or high-risk myelofibrosis, a type of bone marrow disorder. This Phase III clinical trial compares Flonoltinib with the active control drug Ruxolitinib Phosphate. Participants are assigned to one of the two groups based on their risk level using the Dynamic International Prognostic Scoring System DIPSS. The study aims to measure how well these treatments reduce spleen size and improve symptoms over time. Participants take either Flonoltinib 75mg once daily or Ruxolitinib according to prescribed doses twice daily, both taken on an empty stomach. The trial is open-label and conducted at multiple centers, with approximately 105 participants planned for enrollment. Treatment continues until withdrawal criteria are met. The study includes evaluations at various time points up to 24 weeks, focusing on spleen volume reduction and symptom improvement. During the trial, participants undergo regular assessments including physical exams, spleen size measurements using MRI or CT scans, and symptom scoring using the MPN-SAF Total Symptom Score. Blood tests monitor organ function and safety. The primary outcome is the percentage of subjects achieving at least a 35% reduction in spleen volume at week 24. Secondary outcomes include time to spleen response, symptom score changes, and overall survival. Safety and laboratory tests are conducted throughout the study, which lasts several months from enrollment to final assessments.

A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis