- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171860
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
April 29, 2012 updated by: Novartis Pharmaceuticals
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium
- Novartis Investigative Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STI571
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of complete and partial response and relapse
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Secondary Outcome Measures
Outcome Measure |
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Bone Marrow Analysis
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Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
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Disease-Related Symptoms and Signs
|
Organ Involvement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 29, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSTI571ABE01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypereosinophilic Syndrome
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Novartis PharmaceuticalsNo longer availableHypereosinophilic Syndrome (HES)
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