Ruxolitinib for Eosinophilia
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, such as hydroxyurea within 7 days of starting the study and other specific therapies for eosinophilic disorders within 28 days. If you are on corticosteroids, you must be on a stable dose for at least 28 days before starting the trial.
What data supports the effectiveness of the drug Ruxolitinib for treating eosinophilia?
Ruxolitinib has shown effectiveness in treating conditions with high eosinophil counts, like lymphocytic-variant hypereosinophilic syndrome, where it led to complete clinical remission and normalized eosinophil counts in patients. Additionally, it is effective in reducing symptoms and improving quality of life in myelofibrosis, a different condition, suggesting its potential in managing eosinophilia.12345
Is ruxolitinib generally safe for humans?
Ruxolitinib has been used for over a decade to treat myelofibrosis, and while it is generally well tolerated, some patients may experience side effects like anemia (low red blood cell count) and thrombocytopenia (low platelet count), which are usually manageable. Rarely, it can cause skin reactions or increase the risk of infections, so monitoring by a healthcare provider is important.36789
How is the drug Ruxolitinib unique for treating eosinophilia?
Research Team
William Shomali, MD
Principal Investigator
Stanford Cancer Institute Palo Alto
Eligibility Criteria
This trial is for patients with hypereosinophilic syndrome or primary eosinophilic disorders, including those newly-diagnosed, on corticosteroids, or with relapsed/refractory disease. Participants must have symptoms of organ damage or enlargement and an absolute eosinophil count >= 1,500/mm^3 (or >= 500/mm^3 in certain conditions). They should be able to consent and have a performance status <= 3. Exclusions include life-threatening complications from the disease, recent serious infections, low platelet counts, prior JAK inhibitor therapy like ruxolitinib.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive ruxolitinib PO BID on days 1-28. Treatment repeats for up to 6 cycles (28 days each) in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ruxolitinib
Ruxolitinib is already approved in United States, European Union for the following indications:
- Intermediate or high-risk myelofibrosis
- Polycythemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Vitiligo
- Intermediate or high-risk myelofibrosis
- Polycythemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Non-segmental vitiligo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Jason Robert Gotlib
Lead Sponsor
William Shomali
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School