Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

NCT ID: NCT00230334

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-12
• Study Completion Date: 2007-05-31

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.

Conditions

Eosinophilia; Hypereosinophilic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gleevec

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Steven E. Coutre

OTHER

Sponsor Role: lead

Responsible Party

Steven E. Coutre

Professor of Medicine (Hematology) at the Stanford University Medical Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven E Coutre

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

HEMMPD0001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB 79112 (old system)

Identifier Type: -

Identifier Source: org_study_id