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Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

Sponsor
Steven E. Coutre (Other)
Overall Status
Terminated
CT.gov ID
NCT00230334
Collaborator
Novartis (Industry)
5
Enrollment
1
Location
46.6
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Actual Study Start Date :
Jun 12, 2003
Actual Primary Completion Date :
Dec 29, 2006
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305

Sponsors and Collaborators

  • Steven E. Coutre
  • Novartis

Investigators

  • Principal Investigator: Steven E Coutre, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven E. Coutre, Professor of Medicine (Hematology) at the Stanford University Medical Center, Stanford University
ClinicalTrials.gov Identifier:
NCT00230334
Other Study ID Numbers:
  • IRB 79112 (old system)
  • HEMMPD0001
First Posted:
Sep 30, 2005
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Additional relevant MeSH terms:
Hypereosinophilic Syndrome
Eosinophilia
Syndrome
Imatinib Mesylate

Study Results

No Results Posted as of May 10, 2021