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

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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