NCT00944567已完成不适用
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
International Extranodal Lymphoma Study Group (IELSG)20 个研究点 分布在 4 个国家目标入组 125 人开始时间: 2007年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 20
- 主要终点
- response rate on PET scanning following initial chemo-immunotherapy
研究概览
简要总结
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
- •No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
- •Any stage of disease.
- •Age at least 18 years.
- •Fit to receive chemotherapy with curative intent.
- •Able and willing to give informed consent, and to undergo staging including PET scanning
- •Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.
排除标准
- •Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- •Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to involvement by lymphoma.
- •Major impairment of renal function (serum creatinine >2x upper normal) or liver function (ASAT/ALAT >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
- •Known HIV infection. Patients will not be tested routinely.
- •Pregnant or lactating women.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
结局指标
主要结局
response rate on PET scanning following initial chemo-immunotherapy
次要结局
未报告次要终点
研究者
研究点 (20)
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