Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00230334
Recruitment Status : Withdrawn (Withdrawn by PI due to insufficient accrual)
First Posted : September 30, 2005
Last Update Posted : April 13, 2011
Information provided by:
Stanford University

Brief Summary:
The purpose of the trial is to determine the safety and efficacy of Gleevec" in idiopathic hypereosinophilic syndrome (HES) and to characterize the molecular basis for the therapeutic benefit of Gleevec" in HES.

Condition or disease Intervention/treatment Phase
Eosinophilia Hypereosinophilic Syndrome Drug: Gleevec Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Study Start Date : June 2003

Primary Outcome Measures :
  1. To determine the hematologic response rate of imatinib in patients with HES.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:- At study entry, absolute peripheral blood eosinophil count greater than upper limit of normal at the laboratory where the analysis is performed.

  • Patients must have symptomatic disease, e.g. signs or symptoms of organ involvement related to eosinophilia. Examples include pulmonary, cardiac, GI, or central nervous system disease, hepatomegaly, splenomegaly, or skin disease.
  • BCR-ABL-negative by PCR.
  • Patients are imatinib-naive.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Ability to swallow capsules.
 Exclusion Criteria:- Pregnant or nursing women. Patients of childbearing potential must have a negative pregnancy test prior to initiation of study drug. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control during the study and for 3 months following discontinuation of study drug.
  • Serum creatinine >2.0.
  • Total serum bilirubin >2.0 mg/dl. AST(SGOT) and ALT (SGPT) more than 2.5 x the upper limit of normal range (ULN) at the laboratory where the analyses is performed.
  • Presence of clonal T-lymphocyte population by PCR or southern blotting.
  • ECOG Performance Status Score > or = to 3.
  • Busulfan within 6 weeks of starting treatment.
  • IFN-a within 14 days of starting treatment.
  • Low dose cytosine-arabinoside or vincristine within 14 days of starting treatment.
  • Hydroxyurea within 1 day of starting treatment.
  • Prednisone or other immunosuppressives (e.g. azathioprine, cyclosporine-A) within 14 days of starting treatment.
  • AML/ALL-type induction chemotherapy within 4 weeks of starting treatment
  • Persistent peripheral blood count toxicity of grade 2 or higher after receiving AML/ALL-type induction chemotherapy.
  • Treatment with other investigational agents within 28 days of starting treatment.
  • History of non-compliance to medical regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (Grade 3 / 4 New York Heart Association Criteria), unstable angina pectoris or cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of HIV-positivity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00230334

Sponsors and Collaborators
Stanford University
Principal Investigator: Steven Edward Coutre Stanford University Identifier: NCT00230334     History of Changes
Other Study ID Numbers: HEMMPD0001
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action