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Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

Primary Purpose

Eosinophilia, Hypereosinophilic Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Sponsored by
Steven E. Coutre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2005
Last Updated
May 5, 2021
Sponsor
Steven E. Coutre
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00230334
Brief Title
Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
Official Title
Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
terminated by PI due to insufficient accrual
Study Start Date
June 12, 2003 (Actual)
Primary Completion Date
December 29, 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steven E. Coutre
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilia, Hypereosinophilic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gleevec
Primary Outcome Measure Information:
Title
To determine the hematologic response rate of imatinib in patients with HES.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven E Coutre
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

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