NCT00230334终止2 期
Phase II Study of Gleevec (Imatinib Mesylate) in Patients With Idiopathic Hypereosinophilic Syndrome (HES)
Steven E. Coutre2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2003年6月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- To determine the hematologic response rate of imatinib in patients with HES.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.

排除标准
- •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.
- •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
- •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.
结局指标
主要结局
To determine the hematologic response rate of imatinib in patients with HES.
次要结局
未报告次要终点
研究者
Steven E. Coutre
Professor of Medicine (Hematology) at the Stanford University Medical Center
Stanford University
研究点 (2)
Loading locations...
相似试验
终止
2 期
Safety Study of Gleevec® in Children With Pulmonary HypertensionPulmonary HypertensionNCT00583115Indiana University1
已完成
2 期
Gleevec Idiopathic Pulmonary Fibrosis (IPF) StudyLung DiseaseIdiopathic Pulmonary FibrosisPulmonary FibrosisNCT00131274Daniels, Craig E., M.D.120
已完成
不适用
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib MesylateChronic Myeloid LeukemiaHypereosinophilic SyndromeChronic Myelomonocytic LeukemiaPolycythemia VeraMastocytosisNCT00038675M.D. Anderson Cancer Center125
终止
2 期
Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric AdenocarcinomaGastric AdenocarcinomaNCT00209079Emory University5
已完成
2 期
Imatinib Mesylate in Treating Patients With Chronic Myelogenous LeukemiaChildhood Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous LeukemiaNCT00030394National Cancer Institute (NCI)64