Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
This study has been withdrawn prior to enrollment.
(Withdrawn by PI due to insufficient accrual)
Information provided by:
First received: September 28, 2005
Last updated: April 11, 2011
Last verified: April 2011
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Primary Outcome Measures:
- To determine the hematologic response rate of imatinib in patients with HES.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00230334
||Steven Edward Coutre
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 28, 2005
||April 11, 2011
||United States: Institutional Review Board
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors