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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
Must not have
HIV positivity or other known immunodeficiency
D816V KIT-positive systemic mastocytosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3,6,9 and 12 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive or have another known immunodeficiency.
Select...
My condition is D816V KIT-positive systemic mastocytosis.
Select...
My white blood cell or platelet counts are very low, and I may have bleeding.
Select...
My tests show abnormal B cell growth.
Select...
I do not have active tuberculosis or hepatitis B or C.
Select...
I am taking more than 200 mg of fluconazole daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3,6,9 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3,6,9 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
peripheral blood absolute eosinophil count.
Secondary study objectives
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%
Fatigue
15%
Pneumonia
15%
Neutropenia
15%
Cough
13%
Thrombocytopenia
12%
Arthralgia
12%
Nausea
12%
Aspartate aminotransferase increased
12%
Upper respiratory tract infection
12%
Gamma-glutamyltransferase increased
12%
Platelet count decreased
12%
Dyspnoea
11%
Back pain
10%
Nasopharyngitis
10%
Influenza
10%
Myalgia
10%
Headache
10%
Hypertriglyceridaemia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Hyperglycaemia
8%
Oedema peripheral
8%
Conjunctivitis
8%
Constipation
8%
Hypercholesterolaemia
8%
Urinary tract infection
8%
Insomnia
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Amylase increased
7%
Dry eye
6%
Pain in extremity
6%
Leukopenia
6%
Lipase increased
5%
COVID-19
5%
Hyperuricaemia
5%
Hypomagnesaemia
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Cytomegalovirus infection reactivation
5%
Rhinorrhoea
4%
Bronchitis
4%
Abdominal pain
4%
Tremor
3%
Lower respiratory tract infection
2%
Dyspepsia
2%
Pneumonia bacterial
2%
Sepsis
2%
Bronchopulmonary aspergillosis
2%
Herpes zoster
2%
Asthenia
2%
Osteonecrosis
2%
Hypophosphataemia
2%
COVID-19 pneumonia
2%
Pneumothorax
2%
Pulmonary embolism
2%
Cataract
2%
Febrile neutropenia
1%
Respiratory failure
1%
Anal abscess
1%
Anastomotic complication
1%
Pneumococcal infection
1%
Tracheitis
1%
Haemorrhage intracranial
1%
Bacteraemia
1%
Pancreatitis acute
1%
Meningitis viral
1%
Muscular weakness
1%
Epilepsy
1%
Oral candidiasis
1%
Pseudomonal sepsis
1%
Respiratory syncytial virus infection
1%
Catheter site haemorrhage
1%
Bacterial translocation
1%
Respiratory tract infection
1%
Deep vein thrombosis
1%
Tendon disorder
1%
Tachypnoea
1%
Decreased appetite
1%
Cytomegalovirus infection
1%
Enterococcal infection
1%
Lower respiratory tract infection fungal
1%
Adenovirus reactivation
1%
Systemic infection
1%
Fungal infection
1%
Pneumonia cytomegaloviral
1%
Respiratory tract infection viral
1%
Spinal cord compression
1%
Cytomegalovirus test positive
1%
Meningitis cryptococcal
1%
Mycobacterial infection
1%
Infusion related reaction
1%
Syncope
1%
Septic shock
1%
White blood cell count decreased
1%
Measles
1%
Dehydration
1%
Vulvovaginal inflammation
1%
Stomatitis
1%
Respiratory tract infection fungal
1%
Depressed level of consciousness
1%
Escherichia sepsis
1%
Loss of personal independence in daily activities
1%
Acute respiratory distress syndrome
1%
Erysipelas
1%
Pneumocystis jirovecii pneumonia
1%
General physical health deterioration
1%
Spinal compression fracture
1%
Basal cell carcinoma
1%
Squamous cell carcinoma of skin
1%
Post transplant lymphoproliferative disorder
1%
Hypotension
1%
Generalised oedema
1%
Multiple organ dysfunction syndrome
1%
Brain abscess
1%
Acute kidney injury
1%
Renal impairment
1%
Alveolar proteinosis
1%
Hypoxia
1%
Organising pneumonia
1%
Pleuritic pain
1%
Pneumonitis
1%
Pulmonary oedema
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Gastrointestinal ulcer
1%
Atrial flutter
1%
Cardiac failure congestive
1%
Haematemesis
1%
Melaena
1%
Splenic haemorrhage
1%
Corneal erosion
1%
Corneal perforation
1%
Angle closure glaucoma
1%
Ileus
1%
Pyelonephritis
1%
Respiratory tract infection bacterial
1%
SARS-CoV-2 test positive
1%
Skin squamous cell carcinoma recurrent
1%
Squamous cell carcinoma
1%
Completed suicide
1%
Confusional state
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1170
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,678 Total Patients Enrolled
6 Trials studying Hypereosinophilic Syndrome
151 Patients Enrolled for Hypereosinophilic Syndrome
Amy D Klion, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
9 Previous Clinical Trials
1,251 Total Patients Enrolled
4 Trials studying Hypereosinophilic Syndrome
115 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.
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