ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171860
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

September 13, 2005
September 15, 2005
May 1, 2012
September 2002
July 2007   (Final data collection date for primary outcome measure)
Rate of complete and partial response and relapse
Not Provided
Complete list of historical versions of study NCT00171860 on ClinicalTrials.gov Archive Site
  • Bone Marrow Analysis
  • Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
  • Disease-Related Symptoms and Signs
  • Organ Involvement
Not Provided
Not Provided
Not Provided
 
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypereosinophilic Syndrome
Drug: imatinib mesylate
Other Name: Gleevec/Glivec
Experimental: STI571
Intervention: Drug: imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
Not Provided
Not Provided
July 2007   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00171860
CSTI571ABE01
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP