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