A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

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 exclusion criteria may apply.