Testing RVU120 Alone or With Ruxolitinib to Treat Adults With Intermediate or High-Risk Primary or Secondary Myelofibrosis

What this Trial Is About

Researchers are evaluating the drug RVU120 for adult patients with intermediate or high-risk primary or secondary myelofibrosis, a type of bone marrow disorder. The study aims to assess how well RVU120 works alone or combined with ruxolitinib, focusing on its effectiveness, safety, how the body processes the drug, and its biological effects. This is a Phase 2 clinical trial sponsored by Ryvu Therapeutics SA, including patients who have been treated before or cannot use JAK inhibitors or had limited response to such treatments. Participants receive RVU120 at 250 mg every other day on specific days within 21-day treatment cycles, either as a single agent or combined with oral ruxolitinib taken twice daily according to usual dosing guidelines. The trial includes a screening period lasting up to 28 days, followed by treatment cycles, an end-of-treatment visit about 30 days after last dose, and a one-year follow-up phase with check-ins every three months. Doses may be adjusted as needed. During the study, participants undergo various assessments including symptom scoring, spleen size evaluation, blood tests for organ function, and monitoring for side effects. Researchers measure treatment response, symptom changes, spleen response duration, disease progression, survival, and adverse events over 12 months. Participants are monitored regularly and may withdraw anytime. The total study time varies depending on the number of treatment cycles each participant receives.

RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis