Actively Recruiting
Phase 2 Study of Ruxolitinib in Idiopathic Hypereosinophilic Syndrome and Primary Eosinophilic Disorders
Led by William Shomali · Updated on 2025-12-23
10
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
W
William Shomali
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well the drug ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders. This phase II clinical trial aims to determine the overall blood response rate to ruxolitinib and assess its safety. The study also looks at how many patients can reduce or stop corticosteroid use, the duration and time to response, progression-free survival, and overall survival. Participants receive ruxolitinib by mouth twice daily for 28 days per cycle. Treatment may continue for up to six cycles if the disease does not worsen and side effects remain manageable. The study focuses on patients with various eosinophilic conditions, including idiopathic hypereosinophilic syndrome, lymphocyte-variant hypereosinophilia, chronic eosinophilic leukemia, and JAK2-rearranged eosinophilic neoplasms. During the trial, participants undergo regular assessments including blood tests to monitor response and side effects. Researchers track outcomes such as overall response rate, adverse events, corticosteroid use changes, duration and time to response, and survival measures over three years. Participants must meet specific health criteria to join and will be closely monitored throughout the study period.
CONDITIONS
Brief 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
- Diagnosis of idiopathic hypereosinophilic syndrome, lymphocyte-variant hypereosinophilia, chronic eosinophilic leukemia, or JAK2-rearranged eosinophilic neoplasm
- At least two blood readings with an absolute eosinophil count of 1,500/mm³ (or 500/mm³ for certain groups) within the past 3 months, including during screening
- Dependent, intolerant, or refractory to corticosteroids or relapsed/refractory to other therapies
- Symptomatic disease or signs of organ damage possibly related to eosinophilia
- Stable corticosteroid dose for at least 28 days prior to starting treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- Able and willing to provide informed consent
You will not qualify if you...
- Active life-threatening complications from eosinophilic disease such as leukostasis or severe heart or lung dysfunction
- Other WHO-defined myeloid neoplasms associated with eosinophilia besides CEL NOS and JAK2 rearranged neoplasms
- Reactive hypereosinophilia due to connective tissue diseases or eosinophilic granulomatosis with polyangiitis
- Organ-restricted eosinophilia without peripheral blood eosinophilia
- Invasive malignancy within the past 2 years except certain treated early-stage cancers
- Myeloid or lymphoid neoplasms with PDGFRA, PDGFRB, or FGFR1 abnormalities
- Planned stem cell transplant within the first 6 months of treatment
- Major surgery within 4 weeks prior to study entry
- Life expectancy under 6 months
- Known HIV or active hepatitis B or C infection
- Serious infections requiring ongoing antibiotics
- Recent parasitic infection within 24 weeks
- Low platelet count (≤ 25 x 10⁹/L)
- High liver enzymes or bilirubin unrelated to eosinophilic disorder
- End-stage kidney failure
- Recent use of certain therapies including interferon, imatinib, or JAK inhibitors
- Prior ruxolitinib or JAK inhibitor treatment
- Allergic reactions to JAK inhibitors
- Unwillingness to use effective contraception or abstinence as required
- Positive pregnancy test during screening for females of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive ruxolitinib by mouth twice daily in 28-day cycles. Treatment repeats for up to 6 cycles unless disease progression or unacceptable toxicity occurs.
Visits occur during each 28-day treatment cycle
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
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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