Actively Recruiting
Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
Led by William Shomali · Updated on 2025-12-23
10
Participants Needed
4
Research Sites
476 weeks
Total Duration
On this page
Sponsors
W
William Shomali
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
CONDITIONS
Official Title
Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Idiopathic hypereosinophilic syndrome patients with at least two eosinophil counts >= 1,500/mm^3 in the past 3 months, including one during screening
- Dependent, intolerant, or refractory to corticosteroids or relapsed/refractory to other therapies
- Symptomatic or with one or more signs of organ damage related to eosinophilia
- Lymphocyte-variant hypereosinophilia patients with at least two eosinophil counts >= 1,500/mm^3 in the past 3 months, including one during screening
- Abnormal T-lymphocyte immunophenotype by flow cytometry
- Chronic eosinophilic leukemia patients with at least two eosinophil counts >= 500/mm^3 in the past 3 months, including one during screening
- Newly diagnosed or receiving corticosteroids or relapsed/refractory to other therapies
- Increased blasts in blood or bone marrow (>5% and <20%) or clonal cytogenetic/molecular abnormalities
- JAK2-rearranged eosinophilic neoplasm patients with at least two eosinophil counts >= 500/mm^3 in the past 3 months, including one during screening
- Newly diagnosed or receiving corticosteroids or relapsed/refractory to other therapies
- Stable corticosteroid dose for at least 28 days prior to Day 1
- Eastern Cooperative Oncology Group (ECOG) performance status <= 3
- Willing and able to provide informed consent
You will not qualify if you...
- Active life-threatening complications from eosinophilic disease such as leukostasis or severe organ dysfunction
- WHO-defined myeloid neoplasm with eosinophilia other than CEL NOS and JAK2 rearranged neoplasms
- Reactive hypereosinophilia due to connective tissue disease, sarcoidosis, or eosinophilic granulomatosis with polyangiitis
- Organ-restricted eosinophilia without peripheral blood eosinophilia
- Invasive malignancy within past 2 years except certain treated early-stage cancers
- Myeloid or lymphoid neoplasm with eosinophilia and PDGFRA, PDGFRB or FGFR1 abnormalities
- Anticipated hematopoietic stem cell transplant within first 6 months of treatment
- Major surgery within 4 weeks before study entry
- Life expectancy less than 6 months
- Known HIV infection
- Active chronic hepatitis B or C infection
- Serious infections requiring ongoing antibiotics
- Parasitic infection within 24 weeks prior to enrollment
- Platelet count <= 25 x 10^9/L at baseline
- ALT or bilirubin > 4 times upper limit of normal unrelated to eosinophilic disorder
- End-stage renal failure with creatinine clearance or GFR < 15 mL/min
- Use of investigational or commercial therapies for eosinophilic disorder within 28 days of study start
- Use of hydroxyurea within 7 days of study start
- Prior treatment with ruxolitinib or other JAK inhibitors
- Previous allergic reactions to JAK inhibitors or their components
- Unwillingness to use effective contraception or to abstain from heterosexual contact during and after treatment
- Positive pregnancy test for females of childbearing potential during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97201
Terminated
3
University of Utah
Salt Lake City, Utah, United States, 84112
Terminated
4
Fred Hutchinson cancer research center
Seattle, Washington, United States, 98109
Terminated
Research Team
T
Tiffany Nguyen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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