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Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

This study has been withdrawn prior to enrollment.
(Withdrawn by PI due to insufficient accrual)
Sponsor:
Collaborator:
Novartis
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00230334
First received: September 28, 2005
Last updated: April 11, 2011
Last verified: April 2011

September 28, 2005
April 11, 2011
June 2003
Not Provided
To determine the hematologic response rate of imatinib in patients with HES.
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Complete list of historical versions of study NCT00230334 on ClinicalTrials.gov Archive Site
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Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Eosinophilia
  • Hypereosinophilic Syndrome
Drug: Gleevec
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00230334
HEMMPD0001, HEMMPD0001
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Stanford University
Novartis
Principal Investigator: Steven Edward Coutre Stanford University
Stanford University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP