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Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes


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  • Purpose

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    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.


    status: completed
    conditions: Hypereosinophilic Syndrome ; Chronic Eosinophilic Leukemia ; Chronic Idiopathic Hypereosinophilia
    interventions: Imatinib
    phase: Phase 2
    study type: Interventional
    study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
    official title: Therapeutic and Biological Effects of Imatinib Mesylate (STI571) in Primary Hypereosinophilic Syndrome (HES), Chronic Eosinophilic Leukemia (CEL) and Chronic Idiopathic Hypereosinophilia (CIH): a Study From the Northern Italy Leukemia Group (NILG)

  • Further study details (as provided by Northern Italy Leukemia Group)

    primary outcome measures:

    • Response rate

    secondary outcome measures:

    • 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

    enrollment: 25

    study start date: October 2004

    study completion date: December 2007


    Arms Assigned Interventions

    Imatinib: Experimental

    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.

    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.

  • Eligibility

    ages eligible for study: 15 Years and older
    genders eligible for study: Both

    Criteria

    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

  • Contacts and locations

    Please refer to this study by its ClinicalTrials.gov identifier: NCT00787384

    Locations

    Italy  - USC Ematologia Ospedali Riuniti di Bergamo

    facility: Bergamo, Italy, 24128

    Italy  - Divisione di Ematologia Spedali Civili di Brescia

    facility: Brescia, Italy

    Italy  - USC Ematologia Azienda Ospedaliera Università Careggi

    facility: Firenze, Italy, 50134

    Italy  - UO Ematologia, Azienda Ospedaliera ULSS6

    facility: Vicenza, Italy, 36100

  • Sponsors and collaborators

    Northern Italy Leukemia Group

    investigators: Renato Bassan, MD, Principal Investigator, USC Ematologia Ospedali Riuniti di Bergamo

  • More information

    Northern Italy Leukemia Group web page. An operational tool for Group members, mostly devoted to the downloading of Group trials and documents, meeting updates and scientific initiatives of Group members. Access to clinical study area by key words only.

    first received: November 6, 2008
    last updated: November 7, 2008
    ClinicalTrials.gov Identifier: NCT00787384
    health authority: Italy: Ministry of Health

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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