NCT00171860

Brief Summary

The objectives of the study are:

  1. 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. 2.Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
  3. 3.Analysis of patient's blood samples for the detection of activated kinases.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

April 29, 2012

Conditions

Hypereosinophilic Syndrome

Keywords

Hypereosinophilic syndromeImatinib

Outcome Measures

Primary Outcomes (1)

  • Rate of complete and partial response and relapse

Secondary Outcomes (4)

  • Bone Marrow Analysis

  • Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase

  • Disease-Related Symptoms and Signs

  • Organ Involvement

Study Arms (1)

STI571

EXPERIMENTAL
Drug: imatinib mesylate

Interventions

imatinib mesylateDRUG
Also known as: Gleevec/Glivec
STI571

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other diseases associated with hypereosinophilia
  • Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
  • ECOG performance status \>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Leuven, Belgium

Location

MeSH Terms

Conditions

Hypereosinophilic Syndrome

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

EosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2002

Primary Completion

July 1, 2007

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

BE(1)