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Ruxolitinib for Hypereosinophilic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fred Hutchinson cancer research center, Seattle, WAHypereosinophilic Syndrome+11 MoreRuxolitinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Hypereosinophilic Syndrome
  • Chronic Eosinophilic Leukemia, Not Otherwise Specified
  • Leukemia
  • JAK2 Gene Mutation
  • Aplastic Anemia
  • Enlarged Spleen
  • TEL-JAK2 Fusion Protein Expression
  • Eosinophilia
  • BCR-JAK2 Fusion Protein Expression
  • Enlarged Liver
  • Bone Marrow Blast Count

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
CK0804
1
Ruxolitinib
1
Ruxolitinib plus Abemaciclib

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 3 years

3 years
Adverse events
Duration of response (DoR)
Median Progression-free survival (PFS)
Overall response rate (ORR)
Proportion of patients who reduce corticosteroid dose by >= 50% (including patients who become corticosteroid-independent)
Proportion of subjects who become corticosteroid-independent
Time to response (TTR)
Up to 3 years
All cause mortality

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
CK0804
1
Ruxolitinib
1
Ruxolitinib plus Abemaciclib

Side Effects for

Best Available Therapy
23%Pruritus
12%Headache
9%Diarrhoea
9%Upper respiratory tract infection
8%Thrombocytopenia
8%Asthenia
8%Fatigue
7%Dizziness
7%Nausea
7%Night sweats
7%Haematocrit increased
5%Leukocytosis
5%Constipation
5%Influenza
5%Decreased appetite
5%Erythema
5%Weight decreased
4%Arthralgia
4%Hypertension
4%Abdominal pain upper
4%Thrombocytosis
3%Tinnitus
3%Abdominal discomfort
3%Dyspepsia
3%Oedema peripheral
3%Nasopharyngitis
3%Myalgia
3%Pain in extremity
3%Cough
3%Dyspnoea
3%Epistaxis
3%Bronchitis
1%Anaemia
1%Atrial fibrillation
1%Gastrointestinal haemorrhage
1%Rectal haemorrhage
1%Cellulitis
1%Hyponatraemia
1%Bladder transitional cell carcinoma
1%Syncope
1%Extremity necrosis
1%Abdominal pain
1%Pyrexia
1%Flatulence
1%Blood lactate dehydrogenase increased
1%Gamma-glutamyltransferase increased
1%Musculoskeletal pain
1%Hyperuricaemia
1%Osteoarthritis
1%Haematoma
1%Pneumonia
1%Septic shock
1%Neutropenia
1%Meningitis
1%Vertigo
1%Depression
1%Myelofibrosis
1%Respiratory failure
1%Abdominal distension
1%Vomiting
1%Weight increased
1%Muscle spasms
1%Acute myeloid leukaemia
1%Breast cancer
1%Cardiac failure
1%Renal failure
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the Best Available Therapy ARM group. Side effects include: Pruritus with 23%, Headache with 12%, Diarrhoea with 9%, Upper respiratory tract infection with 9%, Thrombocytopenia with 8%.

Trial Design

1 Treatment Group

Treatment (ruxolitinib)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Ruxolitinib · No Placebo Group · Phase 2

Treatment (ruxolitinib)
Drug
Experimental Group · 1 Intervention: Ruxolitinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

William ShomaliLead Sponsor
Incyte CorporationIndustry Sponsor
323 Previous Clinical Trials
46,996 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,182 Previous Clinical Trials
35,091,908 Total Patients Enrolled
Jason Robert GotlibLead Sponsor
4 Previous Clinical Trials
42 Total Patients Enrolled
Jason Gotlib, MD, MSPrincipal InvestigatorStanford Cancer Institute Palo Alto
William E Shomali, MDPrincipal InvestigatorStanford Cancer Institute Palo Alto

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you have lymphocyte-variant hypereosinophilia, you must meet certain requirements.
You have had high levels of a type of white blood cell called eosinophils at least twice in the three months before starting ruxolitinib.
You have a medical condition that does not respond well to corticosteroids or other treatments.
You have had at least two blood tests in the past three months that show a high level of eosinophils, and one of these tests must have been done during the screening period.
You cannot tolerate or have not benefited from corticosteroids, or have not responded to other treatments besides corticosteroids.
You are experiencing symptoms or signs of organ damage that may be related to your medical condition. This can include issues with your skin, lungs, heart, brain, liver, or digestive system, or have an enlarged liver or spleen that is causing discomfort.
Your T-cells are not functioning normally as detected by a specialized test called flow cytometry.
If you have a type of leukemia called chronic eosinophilic leukemia, it must meet specific requirements.
You had at least 2 blood tests in the past 3 months that showed high levels of eosinophils (a type of white blood cell) and one of these tests was done during the screening period.
You are experiencing symptoms of your disease or have signs of organ damage that may be related to eosinophilia (an increase in white blood cells). This can affect your skin, lungs, heart, brain, liver, or gastrointestinal tract, or you have enlarged liver or spleen that is causing symptoms.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

At how many locations is the experiment being conducted?

"This clinical trial is available in 4 distinct locations, such as the University of Utah at Salt Lake City, OHSU Knight Cancer Institute in Portland and Stanford Cancer Institute Palo Alto." - Anonymous Online Contributor

Unverified Answer

How many individuals have enrolled in this clinical investigation?

"25 people who meet the listed requirements are needed to take part in this research. Patients may join either at University of Utah, Salt Lake City or OHSU Knight Cancer Institute, Portland (Oregon)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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