Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

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Brief Title

Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

Official Title

Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

To determine the hematologic response rate of imatinib in patients with HES.


Condition

Eosinophilia

Intervention

Gleevec


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

June 2003



Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven Edward Coutre, , 



Administrative Informations


NCT ID

NCT00230334

Organization ID

HEMMPD0001

Secondary IDs

HEMMPD0001


Study Sponsor

Stanford University

Collaborators

 Novartis

Study Sponsor

Steven Edward Coutre, Principal Investigator, Stanford University


Verification Date

April 2011