Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes

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Brief Title

Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes

Official Title

Therapeutic and Biological Effects of Imatinib Mesylate in Primary Hypereosinophilic Syndromes

Brief Summary

      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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 Safety: Adverse events and serious adverse events

Condition

Hypereosinophilic Syndrome

Intervention

Imatinib

Study Arms / Comparison Groups

 Imatinib
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

October 2004

Completion Date

December 2007

Primary Completion Date

December 2007

Eligibility 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
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Renato Bassan, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT00787384

Organization ID

NILG-HES1-03

Secondary IDs

EUDRACT 2004-002280-24


Study Sponsor

Northern Italy Leukemia Group


Study Sponsor

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


Verification Date

December 2010