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

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Novartis

Status and phase

Terminated
Phase 2

Conditions

Hypereosinophilic Syndrome

Treatments

Drug: imatinib mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171860
CSTI571ABE01

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

STI571
Experimental group
Treatment:
Drug: imatinib mesylate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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