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Tyrosine Kinase Inhibitor
Tyrosine Kinase Inhibitors for Hypereosinophilic Syndrome
Phase 2
Recruiting
Led By Amy D Klion, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of hypereosinophilic syndrome: eosinophilia > 1,500/mm3 on two occasions, no secondary etiology for the eosinophilia despite careful clinical evaluation, and evidence of end organ damage (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporally associated with eosinophilia and not clearly attributable to another cause)
Male or female, at least 2 years of age for imatinib therapy and 18 years of age or older for ruxolitinib therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 9, and 12 months
Awards & highlights
Study Summary
This trial is for patients with a rare blood disorder called hypereosinophilic syndrome, who have not responded to standard treatment. The study will test whether the drug imatinib mesylate (Gleevec) is safe and effective in reducing blood eosinophils in these patients.
Who is the study for?
This trial is for individuals with myeloid hypereosinophilic syndrome, characterized by high eosinophil counts and organ damage. Participants must be at least 2 years old for imatinib or 18+ for ruxolitinib therapy, agree to use effective contraception, and have no secondary causes of their condition. Those already on imatinib may join the dose reduction part of the study.Check my eligibility
What is being tested?
The trial tests tyrosine kinase inhibitors: imatinib mesylate (Gleevec) starting at 400 mg daily, potentially reduced to 100 mg; and ruxolitinib in eligible patients. It aims to reduce blood eosinophilia in myeloid HES patients, assessing safety and efficacy through regular clinical evaluations.See study design
What are the potential side effects?
Possible side effects include bone marrow suppression leading to low blood cell counts, liver enzyme elevation indicating potential liver damage, digestive issues from medication interactions like fluconazole overuse, and risks associated with tuberculosis reactivation during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with hypereosinophilic syndrome, showing high eosinophil levels and organ damage.
Select...
I am at least 2 years old for imatinib or 18 for ruxolitinib treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6, 9, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 9, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
peripheral blood absolute eosinophil count.
Secondary outcome measures
abnormal tyrosine kinase (i.e., FIP1L1-PDGFRA, JAK2 V617F)
clinical, hematologic and molecular remission
peripheral blood eosinophil count
Side effects data
From 2022 Phase 3 trial • 330 Patients • NCT0311260334%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Pneumonia
15%
Neutropenia
15%
Fatigue
15%
Cough
13%
Thrombocytopenia
12%
Nausea
12%
Gamma-glutamyltransferase increased
12%
Aspartate aminotransferase increased
12%
Platelet count decreased
12%
Arthralgia
12%
Dyspnoea
12%
Upper respiratory tract infection
11%
Back pain
10%
Influenza
10%
Headache
10%
Nasopharyngitis
10%
Hypertriglyceridaemia
10%
Myalgia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Constipation
8%
Oedema peripheral
8%
Hypercholesterolaemia
8%
Conjunctivitis
8%
Insomnia
8%
Urinary tract infection
8%
Hyperglycaemia
7%
Dry eye
7%
Amylase increased
7%
Blood alkaline phosphatase increased
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
6%
Leukopenia
6%
Lipase increased
6%
Pain in extremity
5%
COVID-19
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Rhinorrhoea
5%
Hyperuricaemia
5%
Cytomegalovirus infection reactivation
5%
Hypomagnesaemia
4%
Bronchitis
4%
Tremor
4%
Abdominal pain
3%
Lower respiratory tract infection
2%
Sepsis
2%
Febrile neutropenia
2%
Bronchopulmonary aspergillosis
2%
COVID-19 pneumonia
2%
Herpes zoster
2%
Pneumonia bacterial
2%
Osteonecrosis
2%
Dyspepsia
2%
Cataract
2%
Pulmonary embolism
2%
Pneumothorax
2%
Asthenia
2%
Hypophosphataemia
1%
Generalised oedema
1%
Pancreatitis acute
1%
Oral candidiasis
1%
Mycobacterial infection
1%
Pseudomonal sepsis
1%
Respiratory tract infection fungal
1%
Gastrointestinal ulcer
1%
Ileus
1%
Atrial flutter
1%
Completed suicide
1%
Pulmonary oedema
1%
Hypotension
1%
Splenic haemorrhage
1%
Cardiac failure congestive
1%
Haematemesis
1%
Stomatitis
1%
Catheter site haemorrhage
1%
Angle closure glaucoma
1%
Bacterial translocation
1%
Melaena
1%
Meningitis cryptococcal
1%
General physical health deterioration
1%
Fungal infection
1%
Multiple organ dysfunction syndrome
1%
Squamous cell carcinoma
1%
Confusional state
1%
Brain abscess
1%
Cytomegalovirus infection
1%
Bacteraemia
1%
Systemic infection
1%
Enterococcal infection
1%
Erysipelas
1%
Meningitis viral
1%
Escherichia sepsis
1%
Pyelonephritis
1%
Pneumocystis jirovecii pneumonia
1%
Spinal compression fracture
1%
Respiratory tract infection viral
1%
Pneumonia cytomegaloviral
1%
Septic shock
1%
Lower respiratory tract infection fungal
1%
Respiratory tract infection
1%
Measles
1%
Pneumococcal infection
1%
Infusion related reaction
1%
Cytomegalovirus test positive
1%
Respiratory syncytial virus infection
1%
Respiratory tract infection bacterial
1%
Renal impairment
1%
Tracheitis
1%
Depressed level of consciousness
1%
SARS-CoV-2 test positive
1%
Anastomotic complication
1%
Decreased appetite
1%
Acute kidney injury
1%
Pleuritic pain
1%
Squamous cell carcinoma of skin
1%
White blood cell count decreased
1%
Syncope
1%
Dehydration
1%
Tendon disorder
1%
Skin squamous cell carcinoma recurrent
1%
Organising pneumonia
1%
Epilepsy
1%
Basal cell carcinoma
1%
Alveolar proteinosis
1%
Vulvovaginal inflammation
1%
Hypoxia
1%
Pneumonitis
1%
Post transplant lymphoproliferative disorder
1%
Spinal cord compression
1%
Acute respiratory distress syndrome
1%
Haemorrhage intracranial
1%
Tachypnoea
1%
Deep vein thrombosis
1%
Loss of personal independence in daily activities
1%
Respiratory failure
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Anal abscess
1%
Corneal erosion
1%
Corneal perforation
1%
Adenovirus reactivation
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period
Trial Design
2Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
open label ruxolitinib treatment
Group II: ImatinibExperimental Treatment1 Intervention
open label imatinib mesylate treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,409 Total Patients Enrolled
5 Trials studying Hypereosinophilic Syndrome
121 Patients Enrolled for Hypereosinophilic Syndrome
Amy D Klion, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
8 Previous Clinical Trials
1,221 Total Patients Enrolled
3 Trials studying Hypereosinophilic Syndrome
85 Patients Enrolled for Hypereosinophilic Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive or have another known immunodeficiency.My condition is D816V KIT-positive systemic mastocytosis.My white blood cell or platelet counts are very low, and I may have bleeding.My tests show abnormal B cell growth.I do not have active tuberculosis or hepatitis B or C.I am taking more than 200 mg of fluconazole daily.I am willing and able to follow all study rules and attend all appointments.I have been diagnosed with hypereosinophilic syndrome, showing high eosinophil levels and organ damage.I agree to use effective birth control or abstain from sex while on treatment and for 6 months after.I am already taking imatinib and may join the study to adjust my dose.I have been on ruxolitinib for less than 2 months and my doctor agrees I can join.I am at least 2 years old for imatinib or 18 for ruxolitinib treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib
- Group 2: 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.
Does Imatinib present any potential risks to users?
"Our experts at Power rate Imatinib's safety as a 2 due to the limited evidence of its effectiveness in Phase 2 trials and available data on its security."
Answered by AI
Is participation in this experiment open to the public?
"Candidates for this medical trial should have leukemia, eosinophilic and be within the age range of 2 to 100 in order to satisfy eligibility criteria. This research is recruiting a total of 60 participants."
Answered by AI
Are there any opportunities for individuals to join the experiment at this time?
"Clinicaltrials.gov has reported that this clinical trial is in the process of enrolment, with initial postings dating back to September 26th 2002 and a final update on November 16th 2022."
Answered by AI
Are participants aged 18 or older eligible to join this investigation?
"This trial has a broad age range encompassing participants as young as 2 and up to 100 years old."
Answered by AI
What is the participant number for this clinical investigation?
"Affirmative. The information posted on clinicaltrials.gov shows that this research is actively searching for participants, having been first published on September 26th 2002 and updated most recently on November 16th 2022. In total, 60 individuals will be chosen from two medical locations to partake in the trial."
Answered by AI
In what medical scenarios is Imatinib typically utilized?
"Imatinib is a popular choice of medication to treat refractory acute lymphoblastic leukemia (ALL), as well as polycythemia vera, hydroxyurea-resistant and -intolerant cases, and primary myelofibrosis."
Answered by AI
Could you provide a summary of the research conducted on Imatinib?
"Currently, Imatinib is the focus of 145 active studies with 26 trials in their final stage. Though most of these medical experiments are taking place in Beijing, there are 4825 locations across the world running clinical trials for this drug."
Answered by AI
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