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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00171860
Collaborator
(none)
24
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: imatinib mesylate
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
Jul 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: STI571

Drug: imatinib mesylate
Other Names:
  • Gleevec/Glivec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of complete and partial response and relapse []

    Secondary Outcome Measures

    1. Bone Marrow Analysis []

    2. Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase []

    3. Disease-Related Symptoms and Signs []

    4. Organ Involvement []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Leuven Belgium

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00171860
    Other Study ID Numbers:
    • CSTI571ABE01
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    May 1, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Novartis Pharmaceuticals
    Hypereosinophilic syndrome
    Imatinib
    Additional relevant MeSH terms:
    Hypereosinophilic Syndrome
    Syndrome
    Imatinib Mesylate

    Study Results

    No Results Posted as of May 1, 2012