Hypereosinophilic Syndrome
Conditions
Keywords
Hypereosinophilic syndrome, Imatinib
Brief summary
The objectives of the study are: 1. Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein. 2. Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome 3. Analysis of patient's blood samples for the detection of activated kinases.
Interventions
DRUGimatinib mesylate
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories: 1. previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha. 2. not previously treated but with documented Fip1L1-PDGFRA fusion protein
Exclusion criteria
* Other diseases associated with hypereosinophilia * Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit. * ECOG performance status \>3 Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete and partial response and relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Marrow Analysis | — |
| Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase | — |
| Disease-Related Symptoms and Signs | — |
| Organ Involvement | — |
Countries
Belgium
Outcome results
None listed