A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
- Registration Number
- NCT00171860
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories:
- previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha.
- 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 exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STI571 imatinib mesylate -
- Primary Outcome Measures
Name Time Method Rate of complete and partial response and relapse
- Secondary Outcome Measures
Name Time Method Bone Marrow Analysis Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase Disease-Related Symptoms and Signs Organ Involvement
Trial Locations
- Locations (1)
Novartis Investigative Site
🇧🇪Leuven, Belgium