NCT07498205

Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts

A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.

Detailed description

This study is being done to answer this question: Does momelotinib or ruxolitinib do a better job at shrinking the spleen in people who have myelofibrosis with low blood cell counts and haven't been treated yet? Other goals of this study are to find out: * Which drug does a better job of preventing the need for blood transfusions or other treatments * Which drug does a better job of reducing myelofibrosis symptoms * What side effects the drugs cause Momelotinib and ruxolitinib are JAK inhibitors. JAK inhibitors are medicines that block a type of protein that can cause the immune system to be too active, which can cause pain and swelling (including in the spleen). JAK inhibitors are the most commonly used drugs for myelofibrosis that has caused serious symptoms including swelling in the spleen. There are many different JAK inhibitors approved by the FDA to treat myelofibrosis, but no previous studies have compared these drugs with each other for treating myelofibrosis in people with low blood cell counts who haven't been treated yet.

Conditions

• Myelofibrosis
• Myelofibrosis (MF)

Interventions

Type	Name	Description
DRUG	Momelotinib	200 mg daily x 96 weeks.
DRUG	Ruxolitinib	Twice daily per treating investigator discretion not to exceed protocol specified guidelines.

Timeline

• Start date: 2026-08-08
• Primary completion: 2029-08-08
• Completion: 2031-08-08
• First posted: 2026-03-27
• Last updated: 2026-04-09