Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

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

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.

Study Overview

• Status: Terminated
• Conditions: Eosinophilia; Hypereosinophilic Syndrome
• Intervention / Treatment: Drug: Gleevec

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the hematologic response rate of imatinib in patients with HES.

Collaborators and Investigators

• Sponsor: Steven E. Coutre
• Collaborators: Novartis
• Investigators: Principal Investigator: Steven E Coutre, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2003
• Primary Completion (Actual): December 29, 2006
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: September 28, 2005
• First Submitted That Met QC Criteria: September 28, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Hematologic Diseases; Leukocyte Disorders; Syndrome; Eosinophilia; Hypereosinophilic Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: IRB 79112 (old system); HEMMPD0001 (Other Identifier: OnCore)