Status:
TERMINATED
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypereosinophilic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, predniso...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00171860
Start Date
September 1 2002
Last Update
May 1 2012
Active Locations (1)
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1
Novartis Investigative Site
Leuven, Belgium