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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171860
First received: September 13, 2005
Last updated: April 29, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Hypereosinophilic Syndrome
 Drug: imatinib mesylate
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Enrollment: 24
Study Start Date: September 2002
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI571 Drug: imatinib mesylate
Other Name: Gleevec/Glivec

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171860

Locations
Belgium
Novartis Investigative Site
Leuven, Belgium
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171860     History of Changes
Other Study ID Numbers: CSTI571ABE01
Study First Received: September 13, 2005
Last Updated: April 29, 2012
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Novartis:
Hypereosinophilic syndrome
Imatinib

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Imatinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013