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

Phase 2TerminatedNCT00171860

Novartis Pharmaceuticals24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypereosinophilic Syndrome

Interventions

imatinib mesylateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Leuven, Belgium

Outcomes

Primary Outcomes

Rate of complete and partial response and relapse

Secondary Outcomes

Bone Marrow Analysis

Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase

Disease-Related Symptoms and Signs

Organ Involvement

Data from ClinicalTrials.gov

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