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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Hypereosinophilic Syndrome

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171860

CSTI571ABE01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

STI571

Experimental group

Treatment:

Drug: imatinib mesylate