Phase II Gleevec Idiopathic Hypereosinophilic Syndrome

NCT00230334 | Terminated Phase 2 DMC

• 2 other identifiers: IRB 79112 (old system)HEMMPD0001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

Gleevec DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steven E. Coutre: lead
• Novartis: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Eosinophilia; Hypereosinophilic Syndrome

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Steven E Coutre

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine (Hematology) at the Stanford University Medical Center

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: June 12, 2003
• Primary Completion: December 29, 2006
• Study Completion: May 1, 2007
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (1)