Clinical Trial: A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
Brief Summary:
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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Rate of complete and partial response and relapse
Original Primary Outcome:
Current Secondary Outcome:
- Bone Marrow Analysis
- Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
- Disease-Related Symptoms and Signs
- Organ Involvement
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 13, 2005
Date Started: September 2002
Date Completion:
Last Updated: April 29, 2012
Last Verified: April 2012