Ruxolitinib for Thrombocythemia and Polycythemia

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byGabriela Hobbs, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults diagnosed with low-risk essential thrombocythemia or polycythemia vera, without a history of high-risk factors like thrombosis or certain mutations. Participants must have specific blood count levels, organ function within normal ranges, and no severe cardiac issues. They should not be on conflicting medications, pregnant, breastfeeding, or at risk of pregnancy without contraception.

Inclusion Criteria

I have chronic hepatitis B but it's under control with medication.

My essential thrombocythemia is classified as very low, low, or intermediate risk.

I have a cancer history but am only being treated for basal or squamous cell carcinoma.

+10 more

Exclusion Criteria

Patients with >5% blasts on baseline marrow exam or in peripheral blood

Participants with psychiatric illness/social situations limiting compliance with study requirements

History of allergic reactions to compounds of similar composition to ruxolitinib

+8 more

Participant Groups

The trial is testing Ruxolitinib's effectiveness in reducing symptoms of essential thrombocythemia and polycythemia vera. It involves patients who meet specific criteria for these conditions and requires them to have a particular symptom score before starting the treatment.

2Treatment groups

Experimental Treatment

Group I: Ruxolitinib Stage 2Experimental Treatment1 Intervention

Stage 2 will commence based on 3 or more participants in Stage 1 showing a predetermined positive response to Ruxolitinib. In stage 2, participants will be divided into two cohorts: * Very low, Low, and Intermediate-risk ET patients with significant symptom burden and Low-risk PV patients with significant symptom burden * Study cycles are 28 days long, participants in both cohorts will receive: * Ruxolitinib 2x daily for 6 study cycles.

Group II: Ruxolitinib Stage 1Experimental Treatment1 Intervention

In stage 1, participants will be divided into two cohorts: * Very low, Low, and Intermediate-risk ETpatients with significant symptom burden and Low-risk PV patients with significant symptom burden * Study cycles are 28 days long, participants in both cohorts will receive: * Ruxolitinib 2x daily for 6 study cycles.

Ruxolitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Jakafi for: