A Phase 2 interventional study of Imatinib in Hypereosinophilic Syndrome, Chronic Eosinophilic Leukemia and Chronic Idiopathic Hypereosinophilia, sponsored by Northern Italy Leukemia Group. Completed at 4 sites in Italy. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2010-12-29.
Sponsored by Northern Italy Leukemia Group · Phase 2, Interventional, and Treatment
The study was performed to assess: 1) clinical activity of Imatinib in patients with HES, CEL and CIH; 2) correlation between Imatinib activity and specific disease subtype; 3) long-term outcome of HES, CEL and CIH patients treated with Imatinib; 4) safety and tolerability of Imatinib administration.
Hypereosinophilic syndrome (HES), chronic eosinophilic leukaemia (CEL) and chronic idiopathic hypereosinophilia (CIH) are rare disorders characterized by chronic hypereosinophilia with possible damage to various organs due to eosinophilic infiltration and release of cytokines. The therapies of these diseases are largely unsatisfactory and based on the use of a variety of antiproliferative drugs such as corticosteroids, interferon-alfa, cyclosporine, vincristine or hydroxyurea. More often the responses are transient and patients need numerous treatment lines.
In 2001 Schaller et al reported the first case of a patient with HES resistant to conventional treatment that responded to imatinib mesylate. (Schaller, MGM 2001). After that, many authors described cases with hypereosinophilia that achieve a rapid response to Imatinib and in 2003 Cools et al identified a novel tyrosine kinase generated from the fusion of the Fip1-like 1 (FIP1L1) gene to the PDGFRalfa gene associated to hypereosinophilia.
The optimal dose of Imatinib in this setting of patients is still unknown; however, the demonstration of effective and safe clinical doses in a variety of currently studied malignant diseases, suggests that a dose of 100 mg/day increasing weekly of 100 mg/day (maximum dose 400 mg/day), may be employed.
We designed a phase II trial to investigate the clinical anti-proliferative activity, safety and tolerability of escalating doses of Imatinib (entry dose 100 mg/d)administered for 12 total weeks in HES, CEL and CIH patients.
76 studies on the registry are indexed under Hypereosinophilic Syndrome; 9 are open to participants now.
This study's enrollment of 25 is below the median of 48 across 65 interventional studies indexed under Hypereosinophilic Syndrome.
Browse Hypereosinophilic Syndrome studies →Northern Italy Leukemia Group is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received oral imatinib 100 mg/d; in case of unsatisfactory response (less than complete) Imatinib could be increased by 100 mg/die on a weekly basis and up to a maximum of 400 mg/die. Imatinib was discontinued after 12 total weeks of therapy.
Drug: Imatinib
Patients received oral imatinib 100 mg/d; in case of unsatisfactory response (less than complete) Imatinib could be increased by 100 mg/die on a weekly basis and up to a maximum of 400 mg/die. Imatinib wsa discontinued after 12 total weeks of therapy.
Also known as: Gleevec
Response rate
Safety: Adverse events and serious adverse events
Time to response
Diagnostic profile of Imatinib-responsive cases
Duration of responses following drug withdrawal after 12 weeks
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Northern Italy Leukemia Group