JPRN-jRCTs031180139已完成2 期
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
ANDO Kiyoshi0 个研究点目标入组 421 人开始时间: 2019年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 421
研究概览
简要总结
In combination of standard CHOP and rituximab, dose-dense weekly rituximab at early phase of treatment did not improve the PFS in patients with untreated DLBCL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1)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.
- •2)lymphoma with CD20 positive by immunohistochemistry or flow cytometry of biopsy epecimen or surgical specimen
- •3)clinical staging is evaluated by diagnostic imaging procedures within 28 days before entry.
- •4)stage I disease without bulky mass inappropriate for chemo-radiotherapy
- •5)lymphoma cells in peripheral blood: no more than 10,000 /mm3
- •6)ECOG Performance Status: 0-2
- •7)no clinical 0CNS invasion
- •8)having measurable lesion
- •9)no prior chemotherapy, radiotherapy and anti-body therapy
- •10)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)
- •11)written informed consent
排除标准
- •1)Anamnesis of glaucoma
- •2)Diabetes mellitus under treatment with insulin or uncontrolled
- •3)Uncontrollable hypertension
- •4)Coronary artery disorder, cardiomyopathy and heart failure requiring treatment, antiarrhyshmic treated arrhythmia
- •5)HBs antigen positive
- •6)HCV antibody positive
- •7)HIV antibody positive
- •8)Interstitial pneumonia, or plumonary fiblosis
- •9)Severe infection
- •10)Synchronous or metachronous active malignancy. With a history of malignant lymphoma, myelodysplastic syndrome, or leukemia during complete remission
- •11)Interstitial pneumonia, fibroid lung, or severe emphysema
- •12)psychosis or psychiatric symptoms are judged not to be able to participate in this clinical study
- •13)given systemic steroid
研究者
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