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Janus Kinase (JAK) Inhibitor
Ruxolitinib for Eosinophilia
Phase 2
Recruiting
Led By Jason Gotlib, MD, MS
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3.
- Has increased blasts in the blood or bone marrow (> 5% and < 20%), and/or a clonal cytogenetic or molecular abnormality.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial looks at how well a drug called ruxolitinib works in treating patients with a condition called hypereosinophilic syndrome or another condition called primary eosinophilic disorders.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing Ruxolitinib's effectiveness for treating hypereosinophilic syndrome or primary eosinophilic disorders. It's a phase II study which means they're looking at how well it works and its safety in people who fit the criteria.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as infection risk due to immune system suppression; changes in blood counts leading to anemia; liver enzyme elevations suggesting potential liver injury; dizziness; headache; and possible weight gain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do heavy physical work.
Select...
My blood or bone marrow shows a moderate increase in immature cells.
Select...
I have symptoms or signs of organ damage possibly related to my condition.
Select...
I have symptoms or signs of organ damage possibly related to my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Adverse events
Duration of response (DoR)
Median Progression-free survival (PFS)
+3 moreSide effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Paraesthesia
3%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,610 Total Patients Enrolled
Jason Robert GotlibLead Sponsor
4 Previous Clinical Trials
42 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,155 Total Patients Enrolled
1 Trials studying Aplastic Anemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on antibiotics for a serious infection.I have not taken hydroxyurea in the last 7 days.My cancer has specific genetic changes involving the JAK2 gene.I have been diagnosed with chronic eosinophilic leukemia.I have been diagnosed with idiopathic hypereosinophilic syndrome.My condition is a JAK2-rearranged eosinophilic disorder.I am newly diagnosed, on corticosteroids, or my condition didn't improve with treatments other than corticosteroids.I haven't taken any specific drugs for my eosinophilic disorder in the last 28 days.I can take care of myself but may not be able to do heavy physical work.My eosinophilic disease complications are stable and not life-threatening.My blood or bone marrow shows a moderate increase in immature cells.My condition didn't improve with corticosteroids or I can't take them.I have symptoms or signs of organ damage possibly related to my condition.I have symptoms or signs of organ damage possibly related to my condition.I haven't had cancer in the last 2 years, except for certain skin, cervical, or thyroid cancers that were fully removed.I have not had major surgery in the last 4 weeks.My eosinophil levels are high only in certain organs, not in my blood.You have had allergic reactions in the past to JAK inhibitors or any other ingredients used in the medication.I have been treated with ruxolitinib or similar medications before.I have been on a stable dose of corticosteroids for at least 28 days.I have had hepatitis B or C, but it is currently inactive and I am not on specific antiviral treatment.My high eosinophil count is due to a specific underlying condition.I am expected to undergo a stem cell transplant within 6 months of starting the trial.I have been diagnosed with HIV.I am of childbearing age and my pregnancy test during screening was positive.I have been diagnosed with lymphocyte-variant hypereosinophilia.My condition includes a JAK2 mutation.My kidney function is severely impaired.I cannot use corticosteroids due to dependence, intolerance, or ineffectiveness, or my disease has not responded to other treatments.I have a specific type of blood disorder that is not classified as CEL NOS or involves JAK2.My blood cancer is linked to specific genetic changes.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ruxolitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What maladies has Ruxolitinib been commonly utilized to treat?
"Patients suffering from polycythemia vera, polycythemia, or hydroxyurea-resistant/intolerant conditions can be treated with Ruxolitinib."
Answered by AI
Are there remaining vacancies in this clinical trial?
"According to information hosted on clinicaltrials.gov, this research is open for recruitment of patients at the moment of writing. The trial was initially posted in November 15th 2019 with its latest update being made October 5th 2022."
Answered by AI
Are there any other experiments that have used Ruxolitinib for research?
"Ruxolitinib was initially examined in 2002 at the National Institutes of Health Clinical Center located on Rockville Pike. Since then, 93 studies have been concluded and 97 are currently active with many being conducted from Salt Lake City, Utah."
Answered by AI
Is Ruxolitinib a risk-free medication for human consumption?
"Considering the Phase 2 status of this trial, which entails limited evidence in terms of safety but none for efficacy, Power gave ruxolitinib a score of two on its risk assessment scale."
Answered by AI
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