jRCTs031180139已完成不适用
JCOG0601: Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (NHL-R-CHOP-P2/3)
未提供0 个研究点目标入组 422 人开始时间: 2008年1月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 79age old under（—）
- 性别
- All
入选标准
- •Histologically proven CD20 positive diffuse large B-cell lymphoma (WHO classification), excluding histological transformation form marginal zone B cell lymphoma or follicular lymphoma and immunodeficiency associated lymphoproliferative disorders.
- •lymphoma with CD20 positive by immunohistochemistry or flow cytometry of biopsy epecimen or surgical specimen
- •clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry.
- •stage I disease without bulky mass inappropriate for chemo-radiotherapy
- •lymphoma cells in peripheral blood: no more than 10,000 /mm3
- •ECOG Performance Status: 0-2
- •no clinical 0CNS invasion
- •having measurable lesion
- •no prior chemotherapy, radiotherapy and anti-body therapy
- •sufficient organ function
- •i) WBC: more than 3000 /mm3
- •ii) Neutrophil: more than 1000 /mm3
- •iii) Platlets: more than 10x104 /mm3
- •iv) AST: no more than 150 U/L
- •v) male ALT: no more than 210 U/L, female: ALT: no more than 115 U/L
- •vi) T-bil: no more than 2.0mg/dl
- •vii) Creatinine: no more than 2.0mg/dl
- •viii) normal ECG without ischemic change, atrial fibrillation, and ventricular arrhythmia
- •ix) ejection fraction: more than 50% by echocardiogram
- •x) PaO2: more than 65mmHg (room air)
- •written informed consent
排除标准
- •Anamnesis of glaucoma
- •Diabetes mellitus under treatment with insulin or uncontrolled
- •Uncontrollable hypertension
- •Coronary artery disorder, cardiomyopathy and heart failure requiring treatment, antiarrhyshmic treated arrhythmia
- •HBs antigen positive
- •HCV antibody positive
- •HIV antibody positive
- •Interstitial pneumonia, or plumonary fiblosis
- •Severe infection
- •Synchronous or metachronous active malignancy. With a history of malignant lymphoma, myelodysplastic syndrome, or leukemia during complete remission
- •Interstitial pneumonia, fibroid lung, or severe emphysema
- •psychosis or psychiatric symptoms are judged not to be able to participate in this clinical study
- •given systemic steroid
结局指标
主要结局
-
phase II: complete response rate phase III: progression free survival
次要结局
未报告次要终点
研究者
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