NCT04644211

Ruxolitinib in Thrombocythemia and Polycythemia Vera

A Phase 2 Study Of Ruxolitinib In Low-Risk Essential Thrombocythemia And Polycythemia Vera With Significant Symptom Burden

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to see if the drug ruxolitinib is effective in reducing the symptoms caused by low-risk essential thrombocythemia (ET) and polycythemia vera (PV). \- This research study involves the study drug Ruxolitinib.

Detailed description

This is a multi-center, non-randomized, two-stage phase II clinical trial evaluating ruxolitinib in low-risk but symptomatic essential thrombocythemia (ET) and polycythemia vera (PV) patients. This research is being done to see if Ruxolitinib is effective in reducing the symptoms people with essential thrombocythemia (ET) and polycythemia vera (PV) are experiencing. Ruxolitinib is a type of drug that blocks the specific proteins that may be causing the symptoms people with essential thrombocythemia (ET) and polycythemia vera (PV are experiencing. The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits. \- Participants will receive Ruxolitinib for approximately 6 months and if benefitting from it may continue to receive Ruxolitinib for as long as there is no unacceptable side effects or disease progression. It is expected that about 60 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has approved Ruxolitinib for polycythemia vera (PV) but not for people with essential thrombocythemia (ET) and polycythemia vera (PV). Incyte, a biopharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.

Conditions

• Essential Thrombocythemia
• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Pill taken by mouth.

Timeline

• Start date: 2022-03-21
• Primary completion: 2027-07-01
• Completion: 2034-07-01
• First posted: 2020-11-25
• Last updated: 2026-01-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study