KCT0000526招募中未知
An investigator intitiated clnical trial for evaluating the efficacy and safety of 131I-Rituximab treatment as consolidation in the patients with CD20 positive advanced diffuse large B-cell lymphoma after standard combination chemotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. hitologically confirmed CD20 positive diffuse large B cell lymphoma
- •2. chemo-naive patient
- •3. no previous history of radiation therapy
- •4. no previous history of immunotherapy
- •5. measurable lesions?? ??? ??? ?? ?
- •6. =20 years old
- •7. Eastern Cooperative Oncology Group performance status = 2
- •8. adequate liver, kidney, bone marrow function
- •- serum creatinine=1.5 mg/dl or creatinine clearance =60 ml/min
- •- serum transaminases < 5 x upper normal limit
- •- serum bilirubin < 4 mg/dl
- •- neutrophil count=1,500/l, hemoglobin level=8 g/dl,
- •and platelets=100,000/l
- •9. more than 3 months of expected overall survival.
- •10. patient who agree the purpose and intention of this clinical trial
排除标准
- •1. patients with involvement of cerebrospinal fluid
- •2. primary central nervous system lymphoma or diffuse large B cell lymphoma with central nervous system involvement
- •3. HIV positive
- •4. recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
- •5. hemodynamically unstable due to the recent (<12 months) history of severe heart disease such as myocardial infarction
- •6. acute complications of severe lung or metabolic disease
- •7. Combined severe neurological or psychiatric disease
- •8. Unrecovered from infection or other medical disease
- •9. Recent (<30 days) history of enrollment of other clinical trial
- •10. more than 25% of lymphoma marrow involvement
- •11. Previous history drug allergy to the content of 131I-rituximab
- •12. Pregnant or breast-feeding woman
- •13. women of childbearing potential and men not employing adequate contraception
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