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NCT00044304 · ClinicalTrials.gov registry record · Phase 2
Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome
A Phase 2 study of Hypereosinophilic Syndrome and Eosinophilic Myeloid Neoplasm, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT00044304 is a Phase 2 study of Hypereosinophilic Syndrome and Eosinophilic Myeloid Neoplasm that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 70 participants, below the 123-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00044304, a Phase 2 study of Hypereosinophilic Syndrome and Eosinophilic Myeloid Neoplasm, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and efficacy of the tyrosine kinase inhibitor, imatinib mesylate (Gleevec ) in reducing peripheral blood eosinophilia in patients with the myeloid form of hypereosinophilic syndrome (HES). Patients with the hypereosinophilic syndrome who meet a set of criteria designed to select patients with the myeloid form of the disease, as well as patients without myeloid disease who are refractory to standard therapy for HES, will be admitted on this protocol. A thorough clinical evaluation will be performed with emphasis on potential sequelae of eosinophil-mediated tissue damage. A baseline bone marrow will be obtained to exclude leukemia or lymphoma and to assess the degree and nature of eosinophilopoiesis. Bone marrow, blood cells and/or serum will also be collected to test for the presence of a recently described mutation that is associated with imatinib-responsiveness in HES, and to provide reagents (such as DNA, RNA, and specific antibodies) and for use in the laboratory to address issues related to the mechanism of action of imatinib mesylate in HES. Imatinib mesylate will be initiated at a dose of 400 mg daily, the FDA-approved dose for the treatment of chronic myelogenous leukemia. In patients who demonstrate a complete clinical and hematologic response to imatinib therapy and who do not have life-threatening disease, the dose will be decreased gradually to 100mg daily and then discontinued. In order to minimize bone marrow suppression, other myelosuppressive agents will be tapered and discontinued during the first week of therapy with imatinib mesylate. Complete blood counts will be performed weekly for the first month and biweekly thereafter. Clinical assessments will be performed every three months to assess progression of end organ damage. In patients who demonstrate a complete clinical and hematologic response to imatinib therapy and who do not have life-threatening disease, the dose will be decreased gradually
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Imatinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2002-09-26 |
| Est. Completion | 2027-03-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00044304
The ClinicalTrials.gov registry entry for NCT00044304 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (43% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT00044304 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00044304 about?
NCT00044304 is a clinical study titled "Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome". The purpose of this study is to evaluate the safety and efficacy of the tyrosine kinase inhibitor, imatinib mesylate (Gleevec ) in reducing peripheral blood eosinophilia in patients with the myeloid form of hypereosinophilic syndrome (HES). Patients with the hypereosinophilic syndrome who meet a set...
What is the current status of trial NCT00044304?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2002-09-26. Estimated completion is 2027-03-10.
What conditions does trial NCT00044304 study?
This clinical trial studies the following conditions: Hypereosinophilic Syndrome, Eosinophilic Myeloid Neoplasm.
What interventions are being tested in trial NCT00044304?
The interventions under investigation include: Ruxolitinib (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT00044304?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00044304 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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