Brief Title
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Official Title
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
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, 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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Rate of complete and partial response and relapse
Secondary Outcome
Bone Marrow Analysis
Condition
Hypereosinophilic Syndrome
Intervention
imatinib mesylate
Study Arms / Comparison Groups
STI571
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
September 2002
Primary Completion Date
July 2007
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00171860
Organization ID
CSTI571ABE01
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2012