NCT01144754终止不适用
A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP With or Without Radiotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
研究概览
简要总结
This is a multi-center observational study to assess addition of Rituximab in the treatment of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an enrollment period of 60 months. Patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients with DLBCL of the breast.
- •Patients must have CD20 positive tumors.
- •Stage IE or IIE.
- •Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
- •Patients must not have historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- •Patients must have an ECOG performance status 0-
- •Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration):
- •Creatinine Clearance >= 50 ml/min
- •Total bilirubin <= 2.0 mg/dl and AST <= 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be <= 3 x *ULN, and AST <= 5 x ULN.
- •Absolute neutrophil count >= 1500/mm3 and platelet count >= 100,000/mm
- •If documented bone marrow involvement with lymphoma, absolute neutrophil count >= 500/mm^3 and platelet count >= 50,000/mm^
- •Patients must be age >= 18 years.
- •Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
- •Patients must not have an active infection requiring parental antibiotics.
- •Patients with known HIV infection are excluded.
- •Patients must have a normal left ventricular ejection fraction to be eligible.
排除标准
- 未提供
研究者
研究点 (1)
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