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

This study is currently recruiting participants.

Verified by Novartis, May 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171860

Purpose

The objectives of the study are:

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.
Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
Analysis of patient's blood samples for the detection of activated kinases.

Condition	Intervention	Phase
Hypereosinophilic Syndrome	Drug: imatinib mesylate	Phase II

Drug Information available for: Imatinib Imatinib mesylate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	50
Study Start Date:	September 2002

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171860

Contacts

Contact: Novartis

41 61 324 1111

Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSTI571ABE01
Study First Received:	September 13, 2005
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00171860
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Novartis:

Hypereosinophilic syndrome
Imatinib

Study placed in the following topic categories:

Imatinib
Idiopathic hypereosinophilic syndrome
Hematologic Diseases
Hypereosinophilic Syndrome

Leukocyte Disorders
Hypereosinophilic syndrome
Eosinophilia

Additional relevant MeSH terms:

Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Syndrome
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009