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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00230334
Other study ID # IRB 79112 (old system)
Secondary ID HEMMPD0001
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 12, 2003
Est. completion date May 2007

Study information

Verified date May 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date May 2007
Est. primary completion date December 29, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gleevec


Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Steven E. Coutre Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the hematologic response rate of imatinib in patients with HES.
See also
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