Status:
TERMINATED
Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
Lead Sponsor:
Steven E. Coutre
Collaborating Sponsors:
Novartis
Conditions:
Eosinophilia
Hypereosinophilic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Gleev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 12 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00230334
Start Date
June 12 2003
End Date
May 1 2007
Last Update
May 10 2021
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305