EosinophiliaPhase 2NCT00230334
Phase II Gleevec Idiopathic Hypereosinophilic Syndrome
A Phase 2 study testing Gleevec in people with Eosinophilia and Hypereosinophilic Syndrome, run by Steven E. Coutre at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilia, Hypereosinophilic Syndrome
- What is being tested?
- Gleevec
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2003to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
- Conditions
- Eosinophilia, Hypereosinophilic Syndrome
- Being tested
- Gleevec
- Medical subject headings
- Eosinophilia, Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GleevecDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the hematologic response rate of imatinib in patients with HES.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study start12 Jun 2003
- Primary completion29 Dec 2006
- Study completionMay 2007
Why it stopped: terminated by PI due to insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EosinophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven E. Coutre
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Steven E. Coutre, Stanford University
- Investigators
- Steven E Coutre, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230334
- Sponsor's protocol ID
- IRB 79112 (old system)
- Other IDs
- HEMMPD0001
- Status last verified
- May 2021
- First submitted
- 28 Sep 2005
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
- ClinicalTrials.gov ID
- NCT00230334
- Acronym / sponsor ID
- IRB 79112 (old system)
- Conditions
- Eosinophilia, Hypereosinophilic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated by PI due to insufficient accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Steven E. CoutreUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 12 Jun 2003 (actual)
- Primary completion
- 29 Dec 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gleevec | Drug | – |
Primary outcome
To determine the hematologic response rate of imatinib in patients with HES.
Results and safety
The study was stopped early (reason given: terminated by PI due to insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
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A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven E Coutre principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gleevec in people with Eosinophilia and Hypereosinophilic Syndrome, run by Steven E. Coutre at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated by PI due to insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the hematologic response rate of imatinib in patients with HES.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.