Actively Recruiting
Phase 12 Study of Ruxolitinib and Ulixertinib Combination Treatment for Myelofibrosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-07-28
37
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining the drugs ruxolitinib and ulixertinib is a safe and potentially effective treatment for people with myelofibrosis. The study aims to find the highest dose of ulixertinib that causes few or mild side effects when given with ruxolitinib. This study includes both a phase 1 dose escalation part and a phase 2 treatment part to assess the therapys safety and response. In phase 1, participants will receive one of three doses of ulixertinib 450 mg, 300 mg, or 150 mg twice daily combined with ruxolitinib in 28-day cycles. This dose escalation will identify the recommended phase 2 dose RP2D of ulixertinib with ruxolitinib. In phase 2, participants will receive ulixertinib at the RP2D together with ruxolitinib, also in 28-day cycles. Participants will be monitored for dose-limiting toxicities up to 28 days and response to therapy at week 25. The study involves regular assessments to track side effects and treatment effects. Researchers will evaluate treatment safety and effectiveness while participants continue therapy through the study period, which extends until 2028. This allows detailed observation of how participants respond to combination treatment over time.
CONDITIONS
Brief Title
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
Research Team
R
Raajit Rampal, MD, PhD
P
Prioty Islam, MD, MS
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