Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04644211

Ruxolitinib in Thrombocythemia and Polycythemia Vera

Led by Massachusetts General Hospital · Updated on 2026-01-08

60

Participants Needed

4

Research Sites

640 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ruxolitinib in Thrombocythemia and Polycythemia Vera

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with essential thrombocythemia or polycythemia vera by World Health Organization 2016 criteria
  • For essential thrombocythemia: very low, low, or intermediate risk by IPSET criteria
  • For polycythemia vera: low risk by NCCN guidelines
  • MPN-SAF TSS (MPN-10) score above 10 and at least one symptom feature above 5 within 3 months before study
  • Age 18 years or older
  • ECOG performance status 2 or better (Karnofsky 60% or higher)
  • Adequate organ and marrow function as defined by blood counts and liver/kidney tests
  • Previously vaccinated for Herpes Zoster or willing to take prophylactic antiviral medication
  • For chronic hepatitis B: undetectable viral load on therapy if needed
  • For chronic HIV infection: negative for certain viral markers on suppressive therapy if needed
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Essential thrombocythemia patients with high risk by IPSET-R criteria
  • Polycythemia vera patients with high risk by NCCN guidelines
  • More than 5% blasts in bone marrow or peripheral blood
  • Receiving other investigational agents
  • History of splenectomy (may be eligible after approval)
  • Allergic reactions to ruxolitinib or its components
  • Taking strong inhibitors of 3A4 enzyme
  • Uncontrolled illnesses
  • Inadequate liver or kidney function at screening
  • Psychiatric or social conditions limiting study compliance
  • Pregnant or breastfeeding women
  • Unwillingness to use contraception if of childbearing potential or partner of childbearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

3

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

4

Massachusetts General North Shore Cancer Center

Danvers, Massachusetts, United States, 01923

Actively Recruiting

Loading map...

Research Team

G

Gabriela Hobbs, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Ruxolitinib in Thrombocythemia and Polycythemia Vera | DecenTrialz