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Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes (NILG-HES1-03)

This study has been completed.
Sponsor:
Information provided by:
Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00787384
First received: November 6, 2008
Last updated: December 28, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Hypereosinophilic Syndrome
Chronic Eosinophilic Leukemia
Chronic Idiopathic Hypereosinophilia
Drug: Imatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic and Biological Effects of Imatinib Mesylate in Primary Hypereosinophilic Syndromes

Resource links provided by NLM:


Further study details as provided by Northern Italy Leukemia Group:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse events and serious adverse events [ Designated as safety issue: Yes ]
  • Time to response [ Designated as safety issue: No ]
  • Diagnostic profile of Imatinib-responsive cases [ Designated as safety issue: No ]
  • Duration of responses following drug withdrawal after 12 weeks [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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.
Other Name: Gleevec

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
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Divisione di Ematologia Spedali Civili di Brescia
Brescia, Italy
USC Ematologia Azienda Ospedaliera Università Careggi
Firenze, Italy, 50134
UO Ematologia, Azienda Ospedaliera ULSS6
Vicenza, Italy, 36100
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
Principal Investigator: Renato Bassan, MD USC Ematologia Ospedali Riuniti di Bergamo
  More Information

Publications:
Responsible Party: Dr Renato Bassan, NILG
ClinicalTrials.gov Identifier: NCT00787384     History of Changes
Other Study ID Numbers: NILG-HES1-03, EUDRACT 2004-002280-24
Study First Received: November 6, 2008
Last Updated: December 28, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Northern Italy Leukemia Group:
Hypereosinophilic syndrome (HES)
chronic eosinophilic leukaemia (CEL)
chronic idiopathic hypereosinophilia (CIH)
Imatinib
Response
Timing to response

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Eosinophilia
Leukemia
Syndrome
Disease
Hematologic Diseases
Leukocyte Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014