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TerminatedNCT00171860Updated May 1, 2012

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

A Phase 2 interventional study of imatinib mesylate in Hypereosinophilic Syndrome, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-01.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Hypereosinophilic Syndrome

Keywords

  • Hypereosinophilic syndrome
  • Imatinib
03

In context

Hypereosinophilic Syndrome

76 studies on the registry are indexed under Hypereosinophilic Syndrome; 9 are open to participants now.

This study's enrollment of 24 is below the median of 48 across 65 interventional studies indexed under Hypereosinophilic Syndrome.

Browse Hypereosinophilic Syndrome studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    STI571

    Drug: imatinib mesylate

Interventions

  • Drugimatinib mesylate

    Also known as: Gleevec/Glivec

06

What researchers measure

Primary outcomes

  1. Rate of complete and partial response and relapse

Secondary outcomes

  1. Bone Marrow Analysis

  2. Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase

  3. Disease-Related Symptoms and Signs

  4. Organ Involvement

07

Study locations

1 site
  • Novartis Investigative Site
    Leuven, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00171860
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Sep 2002
Primary completion
Jul 2007
Last update
May 1, 2012

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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