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NCT00171860 Clinical Trial

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

Hypereosinophilic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00171860
Other study ID # CSTI571ABE01
Secondary ID
Status Terminated
Phase Phase 2
First received September 13, 2005
Last updated April 29, 2012
Start date September 2002

Study information
Verified date April 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• imatinib mesylate

Locations
Country Name City State
Belgium Novartis Investigative Site Leuven

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of complete and partial response and relapse
Secondary Bone Marrow Analysis
Secondary Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
Secondary Disease-Related Symptoms and Signs
Secondary Organ Involvement
See also
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Recruiting NCT00091871 - A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
Completed NCT01713504 - Identification of New Markers in the Hypereosinophilic Syndrome N/A
Completed NCT00017862 - Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome Phase 2
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Terminated NCT00230334 - Phase II Gleevec Idiopathic Hypereosinophilic Syndrome Phase 2
Recruiting NCT04191304 - A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) Phase 3