Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

Hypereosinophilic Syndrome Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Eosinophilia
• Hypereosinophilic Syndrome
• Syndrome

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.