RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis — POTAMI-61  

Myelofibrosis Clinical Trial

Official title: An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination With Ruxolitinib in Patients With Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

Status Not yet recruiting

Clinical Trial Summary

The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.

Clinical Trial Description

The study schedule consists of a screening period up to 28 days, a 21-day treatment period, an end of treatment visit (30 days) and a 1-year follow-up where participants will be contacted every 3 months for assessment. Study duration for each participant will vary depending on the number of 21-day treatment cycles received. The study is open to participants aged ≥18 years with intermediate or high-risk, primary or secondary MF who have been previously treated, are ineligible for, or had a suboptimal response to JAK inhibitor therapy. Participants must have adequate organ function (kidney, liver) and no history of hematopoietic stem cell transplant. Participants may withdraw from the study at any time at their own request or may be withdrawn at any time at the discretion of the Investigator. ;

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

• NCT number: NCT06397313
• Study type: Interventional
• Source: Ryvu Therapeutics SA
• Contact: Head of Clinical Operations
• Phone: +48-538-898-766
• Email: clinicaltrials@ryvu.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2024
• Completion date: October 2027