Trial record 3 of 210 for: "Hypereosinophilic syndrome"
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: September 13, 2005
Last updated: April 29, 2012
Last verified: April 2012
The objectives of the study are:
- 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.
- Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
- Analysis of patient's blood samples for the detection of activated kinases.
|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:
Genetics Home Reference related topics: PDGFRA-associated chronic eosinophilic leukemia PDGFRB-associated chronic eosinophilic leukemiaU.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
|Study Start Date:||September 2002|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Contacts and Locations