Back to resultsA Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Primary Purpose
Hypereosinophilic Syndrome
Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Hypereosinophilic Syndrome focused on measuring Hypereosinophilic syndrome, Imatinib
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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STI571
Arm Description
Outcomes
Primary Outcome Measures
Rate of complete and partial response and relapse
Secondary Outcome Measures
Bone Marrow Analysis
Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
Disease-Related Symptoms and Signs
Organ Involvement
Full Information
NCT ID
NCT00171860
First Posted
September 13, 2005
Last Updated
April 29, 2012
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00171860
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypereosinophilic Syndrome
Keywords
Hypereosinophilic syndrome, Imatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STI571
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
Gleevec/Glivec
Primary Outcome Measure Information:
Title
Rate of complete and partial response and relapse
Secondary Outcome Measure Information:
Title
Bone Marrow Analysis
Title
Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
Title
Disease-Related Symptoms and Signs
Title
Organ Involvement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
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