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Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes

Information source: Northern Italy Leukemia Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypereosinophilic Syndrome; Chronic Eosinophilic Leukemia; Chronic Idiopathic Hypereosinophilia

Intervention: Imatinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Northern Italy Leukemia Group

Official(s) and/or principal investigator(s):
Renato Bassan, MD, Principal Investigator, Affiliation: USC Ematologia Ospedali Riuniti di Bergamo


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.

Clinical Details

Official title: Therapeutic and Biological Effects of Imatinib Mesylate in Primary Hypereosinophilic Syndromes

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Response rate

Secondary outcome:

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

Detailed description: 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.


Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- patients with a diagnosis of HES, CEL and CIH, who are either previously untreated or

have been treated with corticosteroids, cytotoxic drugs, and IFN.

- age > 15 years.

- signature of a written informed consent(by parents/tutors for patients aged < 18

years). Exclusion Criteria:

- patients with a diagnosis of secondary hypereosinophilia

- age < 15 years

Locations and Contacts

USC Ematologia Ospedali Riuniti di Bergamo, Bergamo 24128, Italy

Divisione di Ematologia Spedali Civili di Brescia, Brescia, Italy

USC Ematologia Azienda Ospedaliera Università Careggi, Firenze 50134, Italy

UO Ematologia, Azienda Ospedaliera ULSS6, Vicenza 36100, Italy

Additional Information

Starting date: October 2004
Last updated: December 28, 2010

Page last updated: August 23, 2015

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